ASQ Section 1313 Boulder, CO                          Date: 1 Feb 2012

Boulder Area's Job Positions. This includes the following cities in 
Colorado: Boulder, Denver, Golden, Fort Collins, Longmont, Loveland,
 etc.

The Boulder Colorado Section of ASQ welcomes individual members 
(not businesses or consultants) to submit a "position wanted" ads.
Of course, ASQ Section 1313 reserves the right to refuse any ad it 
deems inappropriate, and to modify ads as editors are prone to do.

This is a service to the Boulder section's membership.

This information distributed via the Section's Newsletter, 
e-mail list and WEB pages. 

Job Search Resources: job_resources.pdf

Colorado Bioscience Association (CSBA) has
  on its CSBA Jobs and Resume page  
  Job Postings: Members no charge; non-members $100 per post
  Resumes Postings: No charge to members or non-members
  Positions will be posted for 60 days. 
  CBSA is not responsible for search engine results regarding postings


Rocky Mountain Internet User Group jobs and resumes (RMIUG) 
  IT, Software, Quality, Testing, Internet and Computer
  Area: Colorado Springs, Denver, Boulder, FT. Collins
  Members: 14,000+ 

                       Feb 2012 - Jobs Postings

Early Feb email:

*** NEON, Boulder, CO: Systems Integration Engineers ***
Overview
  The National Ecological Observatory Network (NEON) is a $430 million 
    dollar observatory project dedicated to understanding how changes in 
    climate, land use and invasive species impact ecology.  For the next 
    three decades NEON will collect a comprehensive range of ecological 
    data on a continental scale across 20 eco-climatic domains representing 
    US ecosystems.  NEON will use cutting edge technology including an 
    airborne observation platform that will capture images of regional 
    landscapes and vegetation; mobile, relocatable, and fixed data 
    collection sites with automated ground sensors to monitor soil and 
    atmosphere; and trained field crews who will observe and sample 
    populations of diverse organisms and collect soil and water data.  A 
    leading edge cyberinfrastructure will calibrate, store and publish this 
    information.  The Observatory will grow to 300+ personnel and will be 
    the first of its kind designed to detect and enable forecasting of 
    ecological change at continental scales.
Term:
  One year from start date
Summary:
  NEON is looking for an individual to be part of the Systems Engineering 
    team that is tasked with specifying the observatory system, integrating 
    the observatory elements and sub-systems, verifying the system 
    requirements and commission the system in the field.   This is a 
    hands-on position requiring multitasking, creative out-of-the-box 
    thinking and commitment to own a wide range of systems engineering 
    activities including test documentation development and test planning, 
    integration and system test execution, troubleshooting issues, 
    commissioning of observatory system in the field.  
Essential Duties and Responsibilities:
  Analyze system architecture, external interfaces and system requirements
  Identify requirements issues and suggest corrections
  Perform FMEA and reliability analysis
  Develop integration and system test cases and procedures
  Specify and build/setup/configure/troubleshoot test system
  Execute and document integration and system verification and validation 
    tests
  Identify, track and resolve test issues
  Participate in system engineering reviews
  Support development of and execute commissioning tests in the field
  Support the systems engineering team in executing risk management 
    (identification, developing mitigations, etc.)
Required Experience:
  3-5 years experience in a system or device design and test environment 
  Proficient in the following areas:
  1  Analysis and integration of complex, distributed systems
  2  Writing system test cases based upon system requirements and system 
     operational concept
  3  Writing integration test cases based upon system architecture and 
  Interface Control Documents
  4  Writing detailed test procedures for consistent test execution
  5  Specifying and designing test hardware and software
  6  Building and configuring test systems
  7  Developing and using automated functional testing tools/scripts
  8  Evaluating, recommending and implementing automated test tools and 
     automated test scripts
  9  Hands-on system integration test execution and troubleshooting
  10 Systems engineering processes
  11 Requirements capture as well as verification and validation of system 
     requirements
Education:
  Bachelor of Science degree in Electrical Engineering, Mechanical 
    Engineering, Aerospace Engineering or other equivalent technical 
    discipline
 Preferred Experience:
  Experience in the systems engineering discipline
  Expertise with lab test equipment and product evaluation
  Disciplined in quality and product assurance (ISO9001, Six Sigma)
Skills and Abilities
  The individual will be capable of analyzing and understanding system 
    architecture and requirements
  Perform reliability analysis and Failure Mode and Effects Analysis (FMEA)
  Contributing and leading development of integration and system level test 
    cases and procedures
  Specify and setup test systems, perform testing on the different 
    observatory systems in the lab or in the field.  
  Capable of accepting different task out of his/her comfort zone and base 
    knowledge. 
  This position will require some travel (approximately 10%).
  Able to analyze and understand system architecture and requirements
Apply at NEON Careers - Engineering - Systems Integration Engineer - Term - (2) positions
Other NOEN jobs posting at NEON Careers



                       Jan 2012 - Jobs Postings

Mid Jan email:

*** Monster Career and Denver Post Virtual job fair ***
Virtual Career Event Jan 22 - Feb 4, 2012 
- Search local listings, hiring employers and available positions
- Chat live with employers
- Convenient access from home, office or anywhere


*** Emerson Process, Boulder, CO: QA Inspector 1 ***
Emerson Process Management. a leader in helping businesses automate 
  their production, processing and distribution in the chemical, oil and 
  gas, refining, pulp and paper, power, water and wastewater treatment, 
  metals and mining, food and beverage, pharmaceutical and other 
  industries. A division of Emerson, Rosemount DP Flow Design and 
  Operations is a global leader in  high-precision pressure, temperature, 
   level, and flow instrumentation.
Job Title: QA Inspector I
Job ID:  1004677  
Shift: 2nd Shift. Monday - Thursday from 3:45 pm - 2:15 am
Job Location: Boulder, CO
Job Type: Direct Hire
  Relocation is not available for this position
Primary Objectives of Position:
  To inspect dimensional/visual characteristics to established procedures. 
  Provide guidance in the use and interpretation of inspection criteria. 
  Position may be in Receiving, In-process or Final Inspection.
Responsibilities:
- Inspect dimensional/visual characteristics of material, parts and 
    assemblies
- Record inspection results for company and customer reviews; compile data 
    on PC - Electronic and paper files will be created
- Work with detailed instructions, specifications, and codes (ANSI, ASME 
    and others)
- Communicates effectively, interface with production for problem 
    resolution
- Clerical duties as required
- Manage electronic data
- Scanning of MTRs into an electronic data base
Requirements:
- One to two years mechanical inspection experience or equivalent 
    combination of experience and education
- Ability to read engineering controlled prints
- Ability to problem solve
- Good organizational
- Basic PC skills and computer experience
- Basic knowledge of hand tools (calipers, thread gages, ring gages, etc.)
- Good written and verbal communication skills
- Desire to learn and develop within the Quality Assurance field
- High School Diploma or equivalent
Physical Requirements:
- Ability to lift a minimum of 35 lbs (some heavy lifting required)
- Ability to team lift 70 lbs (two people or more)
- Must wear safety shoes and safety glasses and other PPE as required
Interested individuals should apply through our on-line application 
  process. Please visit our general careers page or the specific job: QA Inspector I


                       Dec 2011 - Jobs Postings

None

                       Nov 2011 - Jobs Postings


Early Nov email

*** MillerCoors, Golden, CO: Supplier Quality Specialist
Job id: 1612BR
Dept: Corporate Quality Group, specifically Supplier Quality Group
Priority: 
- Green Belt / Black best experience 
- Experience with DMAIC and FMEA problem solving
Description
- The role of the Supplier Quality Specialist is to identify opportunities
    and lead the development and implementation of solutions that improve 
    the brewing and packaging quality at MillerCoors and its 
    Direct/Packaging Material suppliers.
- This position manages improvement efforts and coaches others on fact 
    based decisions to control, prevent and minimize brewing/packaging 
    quality risks. 
- The incumbent will use MillerCoors systems (Supplier Rating System), 
    good understanding of the MillerCoors Manufacturing Way, sound 
    brewing/packaging quality, direct/packaging material knowledge in 
    association with proven understanding of statistical, mathematical and 
    quality engineering tools to drive corrective actions with Suppliers 
    and Breweries.
- Company wide recognition of expertise that directly influences/impacts 
    the Company Strategy. 
Preferred:  
- BS/BA: Packaging, Engineering, Science or related field 
- 5 to 10 years Quality Assurance experience; brewing and or packaging 
    quality experience a plus 
- Certified Quality Technician and/or Certified Quality Engineer 
- Total Quality Management and/or 6-sigma philosophies; 
- Green Belt or equivalent experience
- Certified HACCP Manager preferred
More information and to apply visit 1612BR - Supplier Quality Specialist


                       Oct 2011 - Jobs Postings

Early Oct email


*** MicroPhage Inc, Longmont, CO: Quality Specialist
Based in Longmont, Colorado, privately-held MicroPhage, Inc. develops 
  innovative, easy-to-use diagnostic products for bacterial identification 
  and antibiotic susceptibility/resistance testing using its proprietary 
  Bacteriophage Amplification Technology platform.
MicroPhage is poised for growth and we need to strengthen our Quality team 
  to support our increased manufacturing scale.  We are seeking an 
  experienced Quality Control/Quality Assurance Specialist ideally with 
  experience in GCP and GMP environments.
Position Summary/Objective
  Under general supervision performs tests and oversees results for raw 
    material, in-process and finished product quality testing and/or 
    release.
  Writes standard operating (SOPs), validation protocols and assists with 
    investigating and resolving assay failures and troubleshooting 
    analytics and equipment.
  Ensures compliance with cGLP and cGMP standards and documentation related 
    to product manufacture.Ability to communicate data and results to team.
Essential Duties and Responsibilities
1.  Performs analytical testing on raw materials, in process and finished 
    product per written procedures. Reviews data obtained for compliance to 
    specifications and reports abnormalities. 
2.  Assist with the review of commercial drug product batch records and all 
    supporting documentation to ensure approval of the commercial lot in a 
    timely manner.  
3.  Writes and revises Standard Operating Procedures/analytical methods and 
    performs method development. Compiles data for documentation of testing 
    methods and procedures. 
4.  Performs internal and external quality audits to ensure compliance with 
    process and procedures, as well as identify improvements.
5.  Leads in the areas of Quality Control method development and method 
    validation.
6.  Leads in the defense of Quality Control data and programs with outside 
    agencies.  (FDA, ISO, etc.)
7.  Leads, manages and assists with analytical and microbiological testing.
8.  Assists staff members with troubleshooting, investigating and resolving 
    assay failures and product failures and closing out discrepancies. 
9.  Performs laboratory investigations, troubleshoots analytical methods 
    and equipment. Submits results of investigations and discusses results 
    with other staff members. Provides hands-on support in the lab to 
    accomplish assigned tasks.
10. Leads in the area of Quality Control Quality Systems.  Able to train 
    staff on requirements.
11. Leads in the areas of Quality Control method development and method 
    qualification.
12. Provides support on various other quality control issues as necessary, 
    ensuring the precision, accuracy, and reliability of Company products. 
13. Assist with the management of Change Control, Deviations, NCMRs and CAPAs. 
14. Assists with the preparation of regulatory submissions, including 
    510(k) and CE marking.
15. Reviews documents impacting regulatory filings such as specifications, 
    stability protocols, batch records, manufacturing formulas, test 
    methods, validation protocols and reports, etc.
16. Maintain current knowledge of cGMP, ISO and related regulations.
17. Takes proper safety precautions to prevent accidents.  Responsible for 
    the safety of self, others, materials and equipment.  Uses all required 
    self-protective and safety equipment and follows all safety 
    regulations, policies and procedures.
18. Additional duties as assigned.
Required Competencies (Skills, knowledge, abilities)
  Detailed knowledge of cGMP, cGLP and ISO standards; understanding of 
    Quality Systems
  Experience reviewing Manufacturing Batch Records, laboratory notebooks 
    and associated supporting data required
  Proficient knowledge in the use of common lab equipment
  Ability to deal accurately with a high level of detail. 
  Solid oral, written communication skills and interpersonal skills.
  Proficiency in the use of Microsoft office suite (Word, Excel, Power 
    Point, Outlook) 
Education and Experience
  Bachelor’s degree in life science and a minimum of 8 years of experience 
    in Quality Assurance/Quality Control in a regulated industry; at least 
    5 years of experience with medical devices or biological diagnostics or 
    equivalent education and experience.
If you believe you have the drive and the talent to make a significant 
  contribution to our growing organization, submit your resume or CV, 
  cover letter describing how your background fits our needs, your salary 
  expectations, and two professional references with 
  subject "job: Quality Specialist" to email: jobs at MicroPhage.
Applicant materials received by October 7, 2011 will be given priority 
  attention.  MicroPhage is an Equal Opportunity Employer.




*** Encision Inc, Boulder, CO: Vice President RA/QA
Description:
  The position is responsible for ensuring domestic and international 
    market clearance for Encision’s current and developing product lines, 
    and for development and implementation of a quality system in 
    compliance with FDA Quality System Regulations, and with quality system 
    requirements in target international markets.
Education, Experience and Skill Requirements:
  Requires a bachelor’s degree, relevant technical training, plus a minimum 
    of 5 years operating experience in regulatory and/or quality assurance 
    function in a medical device company.
  Excellent verbal and written communication skills.
  Must be proficient in Microsoft Office.
  Effective supervisor skills in managing regulatory and/or quality 
    professionals.
To apply send resume and cover letter with subject " job: Vice President RA/QA"
  to Email: HR at Encision




*** Amgen, Longmont, CO:
Sr. Manager. Site Quality Compliance
Auto req: 11548BR 
Job Posting Title: Sr Mgr Quality Compliance 
Career: Category Operations 
Employee Subgroup: Salaried FT 
Country (State/Region): United States - Colorado 
Location: (City) Longmont 
Amgen Job Description:
- Serves as point of contact for regulatory agency or partners during 
    inspections and audits.
- Responsible for management of the inspection/audit process at the site. 
- Leads and performs site audits of laboratory, manufacturing and warehouse 
    facilities (commercial and clinical) as well as Quality Systems to 
    ensure compliance with cGMPs and commitments made to regulatory 
    authorities. 
- Serves as a compliance representative in team and project meetings and 
    interacts with other departments in order to achieve goals to assure 
    current expectations for compliance are met.
- Identifies, interprets and disseminates new regulatory trends, 
   expectations, and compliance documents. Assesses the state of compliance 
   with appropriate regulations and participates in the development of 
   action plans to correct deficiencies.
- Manages the activities of compliance specialists including informing 
    staff of functional and departmental goals, assessing performance, 
    developing skills and capabilities, providing regular feedback and 
    ensuring staff compliance with company policies and practices. 
For more information and to apply go to web site Amgen careers
  Click on Search openings link (opens search page); 
  Enter Keyword: 11548BR; Click on Search button (opens job match page); 
  Click on 11548BR to open detail description page



*** Amgen, Longmont, CO:
Specialist, Site Quality Compliance
Auto req: 11546BR 
Job Posting Title: Specialist Quality Compliance 
Career Category: Operations 
Employee Subgroup: Salaried FT 
Country (State/Region): United States - Colorado 
Location (City): Longmont 
Amgen Job Description:
- Supports the group ownership and management of the external regulatory 
    inspection and partner audit process 
- Provides training to the site on preparing for GMP regulatory inspections 
    and third party audits to maintain inspection readiness 
- Facilitation of the Inspection Readiness Forum; identifies compliance 
    issues, creates a risk rating for each issue and assigns team to 
    address each issue and create playbook 
- Facilitates the development of strategies, mitigation plans, and 
    inspection playbooks for key issues or concerns that may be inspected
- Coordinates mock inspections and executive pressure tests for the site
  Identifies, monitors and tracks effectiveness of action items and 
    commitments from audits, inspections, and inspection readiness
- Lead/perform site internal audits
- Manages inspectors and external auditors by coordinating the schedule, 
    topics, presenters, supporting strategies, communications and close out
- Coordinates audit/inspection responses, monitors effectiveness, and track 
    commitments to closure
- Provide routine Inspection Readiness status updates to site leadership
  Supports the data audit process for regulatory submissions and response 
    to questions
  Coordinates gap assessments for new or updated regulations and mitigation 
    plans for the site 
For more information and to apply go to web site Amgen careers
  Click on Search openings link (opens search page); 
  Enter Keyword: 11546BR; Click on Search button (opens job match page); 
  Click on 11546BR to open detail description page



*** DigitalGlobe, Longmont, CO: Test Engineering Manager. 
General:
- DigitalGlobe is seeking a Test Engineering Manager with large 
    Program experience. The person should have experience testing large, 
    distributed systems and software applications.
- The candidate must be able to learn a complex system, from customer front 
    end through production. The candidate will be a member of the 
   Technology Services team which is responsible for analyzing and 
   integrating changes into the functional layers of the DigitalGlobe 
   Ground System including: core image processing systems, interfaces with 
   business systems, and web services applications. 
A successful candidate for this position would be:
- Responsible for the day-to-day personal management of 10-15 full-time 
    test resources. 
- Responsible for the management of contractor resources as needed to 
    include: time sheet and invoice approval and tracking. 
- Strong Software Quality Assurance knowledge and experience.  
- Manage the System Test Plans that cover all phases of the system test 
    lifecycle including test strategy, test preparation, test data 
    management, test planning and test execution.  
- Formulate testing strategies that will ensure the quality, reliability 
   and completeness of the business services being offered. 
- Define, implement and manage an effective system test process to meet 
    quality goals that are ISO and SOX compliant. 
- Ensure automated testing tools are intelligently applied in support of 
    functional and performance testing activities. 
- Assist with managing and growing; team members, testing tools, quality 
    assurance and testing process to incorporate best practices.  
- Proven ability to work with diverse teams and take ownership of 
    deliverables. 
- Large program experience. 
- Previous experience in a complex product industry is a plus. 
- Experience in imagery, geospatial domains or digital products are a plus.  
For more information and to apply visit Test Engineering Manager



*** DigitalGlobe, Longmont, CO: Test Automation Engineer (Contract) 
Summary
- The Term-of-Project/Contract Test Automation Engineer is responsible for 
   all aspects of quality assurance relative to a complex, distributed 
   software environment. This position works collaboratively to establish 
   standards and develop automation for the Enterprise Quality 
   Organization. 
Responsibilities
- Create or enhance test harnesses or frameworks, as necessary.
- Develop automated tests utilizing QTP or create custom code.
- Document standards and guidelines as necessary for tools, process, and 
   automation.
- Provide accurate test estimates and durations and coordinate with the 
    project schedule.
- Coordinate work activities with other team members.
- Apply best practices and professional principles and techniques to 
   evaluate systems during development.
- Implement test methodologies to ensure requirements compliance and 
    operational readiness for the DigitalGlobe system.  
For more information and to apply visit Test Automation Engineer (Contract)



*** DigitalGlobe, Longmont, CO: Test Engineer (Contract) 
Position Description
- The Test Engineer is responsible for all aspects of quality assurance 
    relative to a complex, distributed software environment.
- This position works collaboratively to ensure our systems quality.
- This position is responsible for generating and executing test cases for 
   the verification of requirements and use cases for an internal software 
   system.
- Regression level testing to ensure that the software release works as 
    expected and does not degrade from the current release.
- Work closely with other Test Engineers, Software Engineers, and System 
    Engineers within the company to gain a solid understanding of the 
    supported internal system, processes, products, and tools to ensure the 
    delivery of a quality release to our production systems.
Responsibilities
- Execute and verify System Level Testing of new software releases and 
    changes made to existing software.
- Execute and verify Regression Level Testing of existing software.
- Isolate software problems, writing clear and detailed defect reports.
- Review and provide input on the accuracy, clarity, and testability of 
    requirement documentation.
- Create and maintain test plans, cases, and results. 
For more information and to apply visit Test Engineer (Contract)



                       Sep 2011 - Jobs Postings
mid Sep email


*** Platinum Registration, Denver, CO: Subcontract Auditor
Job details: 
  Platinum Registration an accredited quality management system registrar 
    located in Denver, Colorado is seeking subcontract auditors to perform 
    National and International certification audits.
  The ideal candidate will be IRCA or RAB certified, have broad industry 
    experience and be an excellent written and verbal communicator.
  Skill in Microsoft products required.  
To apply, please send your resume and cover letter via email 
  with subject: Subcontract Auditor Position
  to: info at Platinum Registration



                       Aug 2011 - Jobs Postings
End Aug email


*** Sound Surgical, Louisville, CO: Director Quality Assurance ***
Assures that the organization has in place a quality system meeting FDA 
  QSR, ISO 13485 and the requirements of other regulatory and standards 
  bodies applicable to the organization by regulation or by choice, by 
  performing the following duties personally or through subordinate 
  supervisors.
For more information and to apply, please contact: 
Kevin Hight, Quality Engineer at Sound Surgical Technologies 
Linked: Kevin Hight 


***  HEI, Boulder, CO: Senior Quality Engineer ***
POSITION:  Senior Quality Engineer
ORGANIZATIONAL RELATIONSHIPS:
- Reports to: Boulder Quality Assurance Manager
- Works closely with: 
  - Manufacturing Engineering
  - Production
  - Service
  - Clients
  - Outside Contractors
  - Suppliers
GENERAL FUNCTION:
- Provides quality assurance and regulatory compliance oversight to 
    assigned projects/products.
- Directs and performs the investigation, disposition, and 
    corrective/preventive action to complaints, process nonconformities, 
    and internal/external audits.
- Applies quality and engineering tools to improve HEI’s quality systems, 
    processes, and products.
- Applies quality tools to specific problems and works with staff, 
    contractors, and suppliers to solve problems.
- Trains and supports the engineering staff on quality tools and techniques 
    such as flowcharts, design of experiments, statistical process control, 
    quality function deployment, hazard analysis, failure mode and effects 
    analysis (FMEA), and fishbone diagrams.
- Monitors and improves HEI’s quality system through internal audits, 
    quality metrics, and corrective/preventive action reviews to the 
    ISO13485 and FDA QSR requirements.
- Develops and implements quality plans, validation master plans, FMEAs, 
    and process control plans. 
- Develops and validates test methods, equipment, and procedures.
PRIMARY DUTIES RESPONSIBILITIES: 
- Performs general function described above with minimal supervision. 
    Operates in the “decide and advise” mode for assigned projects.
- Assumes responsibility for sub-project efforts such as SPC 
    implementation, FMEAs, or validation.
- Responsible for making technical decisions for sub-project efforts. 
- Champions sub-project efforts.
- Provides technical leadership and advises technicians and lower level 
    engineers on assigned projects. Leads technical meetings in specific 
    assigned areas unsupervised.
- Presents and resolves technical problems with the client unsupervised.
- Develops and writes specifications and other documents critical to HEI’s 
    methodologies.
- Critiques and reviews documents and recommends alternate solutions where 
    appropriate.
- Keeps abreast of changing FDA and global regulations and standards. 
- Recommends and implements changes to improve quality system compliance, 
    efficiency, and effectiveness.
- Helps develop quality improvement plans to eliminate defects, reduce 
    costs and cycle times.
QUALIFICATIONS SKILLS:
- Excellent verbal and written communication skills.
  Interpersonal skills  to work effectively with clients and co-workers 
    ranging from operators to executive management.
- Working knowledge of FDA/QSR, ISO, and EU regulations.
- Microsoft PC applications
BACKGROUND EDUCATION:
- Bachelor’s or advanced degree in engineering or physical science.
- Previous experience as a quality engineer in a medical device environment 
    or a combination of five (5) or more years as a quality, biomedical, 
    manufacturing or design engineer in a medical device environment.
- Experience with quality tools and techniques such as flowcharts, design 
    of experiments, statistical process control, quality function 
    deployment, hazard analysis, failure mode and effects analysis (FMEA), 
    and fishbone diagrams required.
- ASQ Certified Quality Engineer preferred. 
- Six Sigma Certification helpful.
PHYSICAL DEMANDS:
- The physical demands described here are representative of those that must 
    be met by an employee to successfully perform the essential functions 
    of this job.
- Reasonable accommodations may be made to enable individuals with 
    disabilities to perform the essential functions.
- While performing the duties of this job the employee is frequently 
    required to sit at a computer.
- The employee will be required to frequently use a keyboard and computer 
    mouse.
- The employee must occasionally lift or carry up to ten (10) pounds,
- The employee must be able to do simple and firm grasping with their left 
    and right hands. 
WORK ENVIRONMENT:
- Office
- Minimal noise level
To apply and for more information, please contact:
  Andy Johnston, Quality Manager
  HEI Inc. Advanced Medical Operations
  4801 North 63rd Street
  Boulder, CO 80301
  Email: Andy Johnston


Mid Aug email


*** Reglera, Wheat Ridge, CO: Quality Assurance Director ****
Position Summary:
  The Quality Assurance Director is responsible for the effective 
    implementation of Quality Assurance processes with Reglera’s clients.
  Activities performed include Quality System implementations, process 
    improvement programs, audits, validation, and CAPAs.
  This position will require expertise in PMA filings and IVDs as
     core knowledge.
Essential Functions:
The Quality Assurance Director has the following responsibilities:
  Day-to-day management and development of quality assurance programs
  Responsible for the ongoing review, strategy development, and operational 
    planning to ensure that all quality assurance programs meet applicable 
    regulations and standards related to PMAs and IVDs.
  Collaboration with organizational leadership in the establishment of 
    quality assurance objectives
  Ensure projects are completed on time and meet Reglera’s quality 
    standards
Education, Training, and Skill Recommendations/Requirements: 
  Requires college degree in related field 
  Requires a minimum of seven years of quality assurance management, 
    preferable in the medical devices and/or pharmaceutical industries;
    10 years of quality assurance management is preferred. 
  Requires strong knowledge of technical strategy as well as systems 
    strategy; must also be able to tie technical and systems strategies 
    into the overall business strategy. 
  Excellent written and verbal communication skills 
  Excellent skills in managing technical and human resources
If you are interested in applying for this open position, please 
  email your resume with subject"job: Quality Assurance Director" to Rosa Quispe 



*** Denver Post: Virtual Career Event ****
Date: Sun, 21 Aug to Sat, 3 Sep 2011
Sponsors: Denver Post and Monster.com 
- Search Local listings
- View the employers and positions
- Chat live with employers
- Convenient access for home, office or anywhere
- Choose the category you are looking for
- Your profile is sent to ALL or just the employers you select
Pre-Registration- Denver Post- 21 Aug
- Enter your email address to be notified when the event begins.
- Pre-register Today and You Could Win a $100 Gas Card



*** Salesforce.com Technology Careers Reception, Boulder, CO ****
Date: Tue, 16 Aug 2011
Location: West End Tavern, 926 Pearl Street, Boulder, CO
Salesforce.com is excited to host a Technology Careers Cocktail Reception on
  Tuesday August 16th from 5:30 pm - 8:30pm at the West End Tavern in Boulder.
  This invitation-only event is geared towards Software Developers, Architects
  and Quality Engineers who are interested in working on exciting products
  such as Chatter and our Force.com platform. Please join us in an informal
  setting with Salesforce technology leaders and employees to learn more about
  cloud computing and what it's like working at Salesforce.com. 
The West End Tavern is located at 926 Pearl Street @ 9th in Boulder, CO.
  Event registration is by invitation only.
  Please register at the following URL by clicking on the
  "Contact the Host" button and fill out the required fields: 
  http://www.eventbrite.com/event/1946308461
We hope you can make it!  Salesforce.com Recruiting 
ADDITIONAL INFO: 
Everything we develop runs in real-time, at cloud scale, supporting hundreds
  of millions of requests thru our API and our UI. This creates technical
  challenges that require innovation at scale. A large part of our
  architecture is driven by metadata in our  multi-tenant environment 
These videos describe some of the key areas we are working on 
 (chatter and our cloud computing platform): 
 youtube video 1 
 youtube video 3
 youtube video 3
Salesforce.com was also just ranked the world's #1 most innovative company by Forbes 
If you have any further questions, please contact 
 email: Marcy Davis  
    or: Abigail Chaney 





*** LGS Innovations, Westminster, CO: Open House Career Fair ****
Date: Wednesday, August 3, 2011
Time: 11:00 AM - 8:00 PM
Place: LGS Innovations' Westmoor Technology Center, Building 9, 
       11300 Westmoor Circle, Westminster CO
Note: Signing Bonuses Offered to Qualified Candidates!
Secure Mobile Communications for the Federal Goverment
Searching for: 
- Software Developers
- RF Engineers
- Hardware and System Test Engineers
- Program and Project Managers
For more information and registration visit LGS, Westiminster Career Fair 
or call 303-920-5303


                       Jul 2011 - Jobs Postings

End Jul email


*** OEM Motor Company, SW Missouri: Quality Manager ****
Seeking Quality Manager for OEM Motor Company in South West Missouri
- Need a degreed person with TS 16949 experience
- Salary to $90,000
- Full Benefits and relocation
Persons interested please contact: Larry Smith
 Phone: 417-830-6957 
 Email: Larry Smith
 Linked-in: Larry Smith

Middle Jul email


*** Oracle, Broomfield, CO: Career Fair ****
The Oracle Broomfield, CO office is growing by leaps and bounds!!! 
Oracle is hosting an onsite Career Fair on Tuesday, July 26th 
Time: 9:00am - 3:00pm 
Location: 500 Eldorado Blvd., Bldg. 1 Broomfield, CO 80021 
Some of the available positions include: 
- Application Integration Developer 
- Filesystems Engineer 
- Flash Qualification Engineer 
- GUI/Usability Engineer 
- Hardware Development Manager 
- Quality Systems Engineer 
- Senior Hardware Design Engineer 
- Senior Software Engineer 
- Software Development Manager 
- Sustaining HW Engineer 
- System Engineer 
- System Reliability Engineer 
If you are unable to attend this event, 
  please submit your resume to: broomfield resume at Oracle


*** DeVry University, Westminster, CO: Career Fair ****
Date: 14 Jul 2011
Time: 11:00am to 3:00pm
Location: DeVry University, Keller Graduate School of Management
          1870 W 122nd Ave. Westminster, CO 80234
  Web site: DeVry University
Information:
DeVry University invites you to our annual career fair, to be held on 
  Thursday, July 14th here at our Westminster campus.
  This event is open to the public.
  There is usually around 35 companies that participate.
  If you are interested in attending, please contact 
  Amber Case, Career Advisor
    Phone: 303.280.7650
    Fax: 303.280.7668
    email: Amber Case
  If you are a recruiter or work for a company with job openings and are 
    interested in having a booth at this event, also contact Amber Case.
  This event is absolutely FREE to attend for both job seekers and 
    employers.


*** Hospira, San Diego, CA & Lake Forest, IL: Senior Quality Engineer ****
Integris Consulting Group has been retained by Hospira a Medical Device 
  Company to find talent for their positions.
Hospira is a global specialty medical device, pharmaceutical and medication 
  delivery company dedicated to Advancing Wellness through the right people 
  and the right products. Through its products, Hospira helps improve the 
  safety, cost and productivity of patient care.
The Role
- The Senior Quality Engineer, On-Market Product Support, Software Devices 
    will be responsible for quality support on all on-market software 
    device activities. Reporting to the Device Quality Manager, On-Market 
    Software, this individual will provide corporate quality support to 
    software manufacturing facilities. He/she will coordinate and lead 
    issue elevation for on-market software device issues while providing 
    Quality leadership cross-functionally to supply chain, commercial, R&D, 
    operations and Program Management in problem-solving for on-market 
    product issues.
Responsibilities
- Support product support teams and act as a Corporate Quality Lead for 
    day-to-day on-market quality issues primarily impacting software 
    devices:
  - Investigation Support
  - Issue Elevation
  - Post-market risk management activities including hazard analysis, 
      FMECA, risk/benefit analysis and represent Quality on post-market 
      Complaint Investigation Review Boards Assessing the impact of quality 
      issues to products
  - Evaluation of adequacy of corrective and preventative actions and 
      determining long term solutions
  - Post market surveillance like Monthly Complaint Reviews, CAPA Review 
      Boards and Management Reviews
  - Field actions/customer communications, including communications with 
      global/ regional quality including EMEA, Latin America, Canada and 
      APAC
  - Determine and execute product holds and support field actions/ recalls
  - Change Management
  - Compliance of supplier operations to product specifications and 
      requirements
  - Regulatory deficiencies or inspections
- Rapidly analyze and respond to business opportunities and threats
Key Capabilities
- Excellent attention to detail
- Process and system oriented
- Energetic and excited about products and prospects
- Strong presence; able to influence and educate
- Solid communication skills and the ability to articulate/ report across 
    levels of the organization
- Demonstrated ability and interpersonal skills to work effectively on 
    cross-functional teams
- Good judgment of priority on issues and activities
- Willing and able to accommodate frequent domestic travel 
   (i.e. approx 20%)
Experience
- A minimum of 5+ years of relevant experience in a software engineering 
    role, i.e. with medical device software
- Quality compliance/ audit skills
- Project management skills to manage remediation activities
- Experience working in an FDA regulated environment
- Able to proactively drive quality into the full life cycle of software 
    development activities
Education
- Bachelor of Science in Electrical Engineering, Computer Science, 
    Biomedical Engineering or equivalent
- Master of Science in Computer or Software Engineering preferred
- ASQ CSQE (Certified Software Quality Engineer) preferred
Persons interested please contact:
  Linda Briscoe
  Executive Recruiter, Integris
  Phone: 847-651-9236
  Email Linda Briscoe



                       Jun 2011 - Jobs Postings

Mid Jun 2011 email


*** Covidien, Boulder, CO: Reliability Engineers   ****
Covidien, Energy Based Devices in Boulder CO, has openings for the 
  following positions. 
- Energy-based Devices Principal Design Quality / Reliability Engineer 
    (requisition number: 11-1362)
- Energy-based Devices Sr. Design Quality / Reliability Engineer 
    (requisition numbers 11-1361) 
Visit web page http://careers.covidien.com/ Covidien careers section 
  Click on "Search Jobs" link; 
  Click on "Search US Positions by Criteria" link
  In Keywords enter specific requisition number
For details contact 
  Gary Deniston, ASQ CSQE, CRE, DFSS Black Belt
    Group Leader, Systems Design Quality Engineering
    Covidien, Energy Based Devices
    5920 Longbow Drive, Boulder, CO 80301-3299
Work email: Gary Deniston
Work Phone:  303-530-6212



*** NEON, Boulder, CO: Systems Engineer    ****
SYSTEMS ENGINEER 
Overview
- The National Ecological Observatory Network (NEON) is a $430 million 
    dollar observatory project dedicated to understanding how changes in 
    climate, land use and invasive species impact ecology.
- For the next three decades NEON will collect a comprehensive range of 
   ecological data on a continental scale across 20 eco-climatic domains 
    representing US ecosystems.
- NEON will use cutting edge technology including an airborne observation 
   platform that will capture images of regional landscapes and vegetation; 
    mobile, relocatable, and fixed data collection sites with automated 
   ground sensors to monitor soil and atmosphere; and trained field crews 
    who will observe and sample populations of diverse organisms and 
    collect soil and water data.
- A leading edge cyberinfrastructure will calibrate, store and publish this 
    information.
- The Observatory will grow to 300+ personnel and will be the first of its 
    kind designed to detect and enable forecasting of ecological change at 
    continental scales.
Summary:
- NEON is looking for an individual to be part of the Systems Engineering 
    team that is tasked with specifying the observatory system, integrating 
    the observatory elements and sub-systems, verifying the system 
    requirements and commission the system in the field.
- The successful candidate will have hands-on experience analyzing systems, 
    performing requirements analysis and management, performing system 
    integration, verification and validation, troubleshooting issues, 
    commissioning systems.
- The individual will be capable of analyzing and documenting system 
    architecture and requirements, perform reliability analysis and Failure 
    Mode and Effects Analysis (FMEA), contributing to and leading 
    development of integration and system level test cases and procedures, 
    perform and lead test activities on the different observatory systems 
    in the lab or in the field, perform requirements traceability, lead 
    troubleshooting activities and track issues to closure.
- The individual will be capable of accepting different task out of his/her 
    comfort zone and base knowledge.  This is a hands-on position requiring 
    multitasking, creative out-of-the-box thinking and commitment to own 
    and lead a wide range of systems engineering activities including test 
    documentation development and test planning, FMEA and reliability 
    analysis, integration and system test execution, troubleshooting 
   issues, commissioning of observatory system in the field.  
Essential Duties and Responsibilities:
- Analyze and document system architecture, external interfaces and system 
    requirements
- Identify requirements issues and suggest corrections
- Perform and/or lead FMEA and reliability analysis - derive requirements 
    and test cases
- Lead development of integration and system test cases and procedures
- Specify and build/setup/configure/troubleshoot  test system
- Execute and document integration and system verification and validation 
    tests
- Perform requirements traceability
- Identify, track and resolve issues
- Participate in system engineering reviews
- Analyze and understand Operations Concept
- Support development of and execute commissioning tests in the field - 
    based on Operations Concept
- Support the systems engineering team in executing risk management 
    (identification, developing mitigation, etc.)
- Support implementation of program Product/Quality Assurance processes to 
    include auditing and allocation of PA requirements across project 
    functions and support teams 
- Support the systems engineering team in project oversight of Integration, 
    Verification and Commissioning test activities
Required Experience:
- 5 - 10 years experience in a design and development environment 
- Proficient in the following areas:
  - Analysis and integration of complex, distributed systems
  - Systems engineering plans and processes
  - Requirements analysis and management
  - Requirements verification and validation, incl. writing system test 
      cases based upon system requirements and system operational concept
      architecture definition and Interface Control Documents (ICDs)
  - Writing integration test cases based upon system architecture and ICDs
  - Hands-on system integration and verification test execution and 
      troubleshooting
  - Design review process execution/facilitation
  - Configuration management and quality management plans and processes
Education:
- Bachelor of Science degree in Electrical Engineering, Mechanical 
    Engineering, Aerospace Engineering or other equivalent technical 
    discipline
Preferred Experience:
- 5 plus years experience in the systems engineering discipline
- Masters degree in Electrical Engineering, Mechanical Engineering, 
    Aerospace Engineering or other equivalent technical discipline
- FMEA and reliability analysis experience
- Writing detailed test procedures for consistent test execution
- Specifying and designing test hardware and software
- Building and configuring test systems
- Developing and using automated functional testing tools/scripts
- Evaluating, recommending and implementing automated test tools and 
    automated test scripts
- Expertise with lab test equipment and product evaluation
- Disciplined in quality and product assurance (ISO9001, Six Sigma)
Persons interested please Apply at NEON Careers web page
NEON Inc. is an Equal Opportunity Employer. Women, Minorities, Veterans 
  and Disabled Persons are encouraged to apply.



*** NEON, Boulder, CO: Systems Integration and Test Engineer ****
Systems Integration and Test Engineer
Overview
- The National Ecological Observatory Network (NEON) is a $430 million 
    dollar observatory project dedicated to understanding how changes in 
    climate, land use and invasive species impact ecology.
- For the next three decades NEON will collect a comprehensive range of 
   ecological data on a continental scale across 20 eco-climatic domains 
    representing US ecosystems.
- NEON will use cutting edge technology including an airborne observation 
   platform that will capture images of regional landscapes and vegetation; 
    mobile, relocatable, and fixed data collection sites with automated 
   ground sensors to monitor soil and atmosphere; and trained field crews 
    who will observe and sample populations of diverse organisms and 
    collect soil and water data.
- A leading edge cyberinfrastructure will calibrate, store and publish this 
    information.
- The Observatory will grow to 300+ personnel and will be the first of its 
    kind designed to detect and enable forecasting of ecological change at 
    continental scales.
Summary:
- NEON is looking for an individual to be part of the Systems Engineering 
    team that is tasked with specifying the observatory system, integrating 
    the observatory elements and sub-systems, verifying the system 
    requirements and commission the system in the field.
- The successful candidate will have hands-on experience analyzing systems, 
    performing integration testing and troubleshooting issues.
- The individual will be capable of analyzing and understanding system 
    architecture and requirements, perform reliability analysis and Failure 
    Mode and Effects Analysis (FMEA), contributing and leading development 
    of integration and system level test cases and procedures, specify and 
    setup test systems, perform testing on the different observatory 
    systems in the lab or in the field.
- The individual will be capable of accepting different task out of his/her 
    comfort zone and base knowledge.
- This is a hands-on position requiring multitasking, creative out-of-the-
    box thinking and commitment to own a wide range of systems engineering 
    activities including test documentation development and test planning, 
    FMEA and reliability analysis, integration and system test execution, 
    troubleshooting issues, commissioning of observatory system in the 
    field.  
Essential Duties and Responsibilities:
- Analyze system architecture, external interfaces and system requirements
- Identify requirements issues and suggest corrections
- Perform FMEA and reliability analysis
- Develop integration and system test cases and procedures
- Specify and build/setup/configure/troubleshoot  test system
- Execute and document integration and system verification and validation 
    tests
- Identify, track and resolve test issues
- Participate in system engineering reviews
- Support development of and execute commissioning tests in the field
- Support the systems engineering team in executing risk management 
    (identification, developing mitigations, etc.)
Required Experience:
- 3-5 years experience in a system or device design and test environment 
- Proficient in the following areas:
  - Analysis and integration of complex, distributed systems
  - Writing system test cases based upon system requirements and system 
      operational concept
  - Writing integration test cases based upon system architecture and 
      Interface Control Documents
  - Writing detailed test procedures for consistent test execution
  - Specifying and designing test hardware and software
  - Building and configuring test systems
  - Developing and using automated functional testing tools/scripts
  - Evaluating, recommending and implementing automated test tools and 
      automated test scripts
  - Hands-on system integration test execution and troubleshooting
  - Systems engineering processes
  - Requirements capture as well as verification and validation of system \
      requirements
Education:
- Bachelor of Science degree in Electrical Engineering, Mechanical 
    Engineering, Aerospace Engineering or other equivalent technical 
    discipline
Preferred Experience:
- Experience in the systems engineering discipline
- FMEA and reliability analysis experience
- Expertise with lab test equipment and product evaluation
- Disciplined in quality and product assurance (ISO9001, Six Sigma)
Persons interested please Apply at NEON Careers web page
NEON Inc. is an Equal Opportunity Employer. Women, Minorities, Veterans and 
  Disabled Persons are encouraged to apply.



*** Recruiter, Boulder, CO: Supplier-Source Quality Engineer ****
Primary responsibilities:
  The role requires leadership, knowledge of technical aspects of 
    manufacturing, passion for improvement, structured data driven 
    mind-set, intellectual accuracy, communication capabilities both 
    internally with different functions and externally with suppliers and 
    also customers. 
  Work with suppliers to continuously improve the suppliers quality level, 
    reducing both escaping defects and associated cost of quality
  Ensure material released to production meets all quality requirements
  Perform qualification and surveillance audits of suppliers to verify 
    compliance requirements and expectations
  Assist suppliers in root cause analysis (RCA) and corrective actions (CA) 
    in case of escaping defects, in order to prevent recurrence 
  Assist with supplier Identification and a qualification process 
  Communicate with suppliers on critical characteristic identification and 
    measurement
  Manage supplier change requests along with changes initiated by the 
    supplier throughout the organization
  Develop and report supplier metrics
To be considered, candidates must have the following background:
Education and Certifications
  Bachelors degree in technical engineering field
  5 years industrial/manufacturing quality experience
Specific skills and knowledge
  Experience directing supplier quality efforts
  Strong analytical and interpersonal skills
  Ability to travel 50% is required
Persons interested email or send your resume and cover letter to:
Denise Register Shugerman, Solar Recruiter
  Global Recruiters of Boulder, 1630 30th street, Suite A-221, Boulder CO 80301
Office phone: 303.545.6602
Office email: Denise Register Shugerman
Office web: Global Recruiters of Boulder




                       May 2011 - Jobs Postings

End May 2011 email


*** Medical Company, Louisville, CO: Software QA Engineer  ****
Job type:
- The Software Quality Engineer candidate should have strong exposure to 
    the Code of Federal Regulations (CFR).
- In addition to regulatory knowledge, working experience within a medical 
    device manufacturer's regulatory group is a plus.
- Previous experience in auditing or being a member of an audit team is 
    desired.
- If no audit team experience, at least experience within a GMP-regulated 
    work environment is required. This is a contract job, to last 3-6 
    months, potentially longer.
Position Description:
- Provide software quality engineering support of image guided systems 
    through the product life cycle.
- Participate in the software assurance of design, manufacturing, and 
    testing of systems and components in company’s products.
- Analyze field data for product improvement opportunity. 
Position Responsibilities:
- Participate in establishing and reviewing software 
    specifications/requirements for products in Linux OS with C programs. 
- Review changes to designs and processes and assess impact to assure 
    reliability requirements are met, including preparing, reviewing, or 
    approving change controls 
- Prepare, review, change control and approve verification and 
    qualification test protocols and reports for assigned projects.
- Provide well-written reports and supporting documentation. 
- Evaluate field performance of assigned products by analyzing field data. 
- Investigate and evaluate product field problems and nonconforming 
    product.
- Work with suppliers to resolve product performance issues or failures. 
- Improve data collection tools, methods and processes for generating 
    failure rates and other product performance data. 
- Participate in activities to establish and maintain the Risk Management 
    process, including application of ISO 14971. Contribute to hazard 
    assessments and FMEAs. 
- Prioritize and manage multiple priorities effectively with minimal 
    direction. 
- Provide solutions to a wide range of difficult challenges.
- Work independently to determine and develop solutions that are 
    imaginative, thorough, practicable, and consistent with organizational 
    objectives. 
- Follow all Quality System Practices as defined per Companies practices, 
    policies and Standard Operating Procedures to ensure that FDA, ISO and 
    European Medical Device quality standards and regulations are met where 
    applicable. 
Qualifications:
- 5+ years of previous experience in software quality position in a 
    regulated environment with B.S./B.A./M.S/M.A. 
- Well developed oral and written communication skills. 
- Experience working with cross-functional design/development teams. 
- Previous experience in managing multiple projects having multiple tasks. 
- Working knowledge of FDA Quality System Regulations, Medical Device 
    Directive, ISO 13485, ISO 14971, WEEE, RoHS, and IEC 60601 standards. 
- Knowledge of statistical techniques and reliability tools.
- Proficient with data analysis. 
- Formal training in Six Sigma methods combined with project deployment 
    experience at the green belt or greater level is highly desirable. 
About us: 
- SQA Services, Inc. is a quality, supply chain, and engineering services 
    provider with customers in the healthcare/life sciences, 
    aerospace/defense, and high-technology arenas. SQA serves clients 
    ranging from Amgen to Whirlpool.
- We manage, through our global network of Associates, coordinated and 
    focused programs in supplier auditing, supplier development and risk 
    assessment, lean/six sigma, inspection, and more.
- Our clients benefit from the turn-key nature of our global team, who act 
   as extensions of their own supplier quality groups. 
Persons interested email or send your resume and cover letter to:
  Tami Parker
  Associate Development
  SQA Services, Inc. - "Global Quality on Demand"
  550 Silver Spur Road, 3rd Floor
  Rolling Hills, CA 90275
  Phone (310) 802-4415
  email: Tami Parker



*** Spherion Corp, Plattsburgh, NY: 14001 QC consultant ****

Spherion Corporation is currently recruiting for one of the top companies 
in Plattsburgh, NY. The position is for a QC Consultant with experience in 
ISO 14001, for a 3 month period, pay rate is based on experience and is 
negotiable, and hotel expenses are covered.

Persons interested email or send your resume and cover letter to:
Jana Venable
  Branch Manager
  Spherion Staffing
  7061 Rte 9 Plattsburgh, NY 12901
  Phone: 518 825-2060
  Fax: 518 825-2064
  email: Jana Venable, Spherion


Mid May 2011 email


*** Unisyn Medical Technologies, Golden, CO: QA/RA Manager ****
JOB DESCRIPTION
- Revised 5/13/2011
- Position: QA/RA Manager 
- Reports to: VP, QA/RA and R&D
- Status: Regular/Full Time/Exempt
- Location: 1150 Catamount Drive, Golden, CO
Position Description:
- Lead Quality Assurance and regulatory compliance staff and activities, 
    including Quality Systems, Operations, Supplier Quality, and Design 
    Control. 
Roles & Responsibilities:
- Facilitate continuous improvements across business units and functions.
- Identify and monitor requirements of all relevant regulations (US and 
    international) and standards and ensure compliance.
- Manage the development, deployment, and maintenance of Unisyn’s Quality 
    Systems and programs.
- Serve as Unisyn’s Management Representative; interface with external 
    authorities, customers, auditors, etc. regarding Unisyn’s Quality 
    Systems and programs.
- Supervise and direct activities of QA/RA staff.
- Other duties as assigned.
Requirements:
Education & Certifications
- Bachelor of Science Degree in a technical discipline
- Relevant professional certifications
Experience
- 10+ years experience in leadership role in a regulated industry
Competencies
- Ability to objectively and impartially assess situations in business and 
    make decisions and recommendations based on evidence
- High level of attention to detail and accuracy
- Strong organizational skills and ability to prioritize tasks
- Excellent verbal and written English language skills
- Ability to establish and maintain effective working relationships with 
    co-workers, customers, and vendors
- Ability to react quickly and adapt to changes in priorities, 
    circumstances and direction
- Ability to work effectively with minimum supervision
Persons interested send your resume and cover letter 
  with subject: "Job QA/RA Manager" to:
  email: jmorris AT unisynmedical.com 
  and email: HR AT unisynmedical.com



*** Minneapolis, MN: Lean Six Sigma Manager ****
Hiring for an Exciting Lean Six Sigma Manager role! 
Based in Minneapolis for a high volume manufacturing site
Job Description
Position Scope/Summary
- Provide leadership, training and support to the Site in an effort to 
    achieve "Best-in-Class" performance by eliminating waste in all 
    manufacturing and business processes, radically improving cycle times 
    to our customers and creating an environment focused on continuous 
    improvement.
Key Result Accountabilities
Primary:
- Lead the training of the Site employees in Lean Enterprise principles;
- Perform facility-wide training in Lean Manufacturing tools, including the 
    use of Kaizen events, Value-Stream Mapping, Single-Piece Flow, TPM, 
    Setup Reduction, 5S, Kanban, etc.;
- Develop and deploy the annual facility Continuous Improvement Plan, 
    consistent with the Hoshin Planning cycle and Corporate Continuous 
    Improvement Plan;
- Lead the delivery of significant, quantifiable, annualized cost savings;
- Develop and improve manufacturing processes through the use of Lean 
    Sigma;
- Lead the Site deployment of hourly, daily, weekly, and monthly metrics, 
    ensuring that collection and monitoring of this information is 
    meaningful in the identification of areas requiring process improvement 
    or corrective action;
- Lead problem solving efforts both internally and externally, working 
    closely with customers and QA on internal and external corrective and 
    preventive actions; and
- Partner with Supply Chain Management in the development of partnerships 
    with suppliers and maximizing the use of VMI programs, Kanbans, and 
    consignment inventory with key customers.
Secondary:
- Drive six sigma process improvement methodologies as the facility wide 
    "thinking tool.";
- Lead the training of the workforce in Six Sigma tools & techniques ;
- Assist QA with process capability validation, the implementation and 
    qualification of new equipment (i.e. new machines, automation) and the 
    certification of primary and secondary processes using statistical 
    methods, capability studies, etc.
- Assist Finance in tracking the financial impact and benefits of Lean and 
    Six Sigma initiatives, establishing metrics consistent with Lean 
    Thinking;
- Assist in the establishment of standard costs for new and existing 
    products, where impacted by Lean deployment initiatives;
- Assist in financial justification of new equipment as it applies to Lean 
    deployment or process improvement;
- Maintain a current knowledge base and personal development plan to retain 
    leadership skill set in the Lean Sigma disciplines.
Desired Skills & Experience
Required Experience & Qualifications:
- An undergraduate degree in Engineering, Industrial Technology or Business 
    is required;
- Six Sigma Training Required; Black Belt certification a plus
- Formal Lean training required;
- A minimum of five years experience in deployment of Lean Manufacturing;
- 3-5 years of management or supervision experience a plus; 
- Demonstrated track record of Lean implementation yielding measurable 
    performance improvement or transformation from traditional batch 
    manufacturing processes;
- Experience in a "Made-to-Order" product environment a plus. 
- Demonstrated strong verbal and written communication skills, analytical 
    skills, statistical and mathematical abilities and interpersonal skills. 
- Experience in cost conscious manufacturing environments (automotive, 
    consumer electronics, appliances) considered a plus. 
- The ability to handle highly confidential information in an appropriate 
   manner. 
- The ability to work with all levels of staff 
Company Description
  International contract manufacturing company.
  Additional Information
  Posted:May 18, 2011
  Type:Full-time 
  Experience:Mid-Senior level 
  Functions:Manufacturing  
  Industries:Medical Devices  
  Compensation:Salary + Bonus
  Referral Bonus:$1500 
  Job ID:1626238
Persons interested email your resume and cover letter with Job ID:1626238
  to recruiting AT leansixsigmaexperts.com
  or apply through LinkedIn job: Exciting Lean Six Sigma Manager role, Minneapolis, MN
  From Linkedin: Jayaprakash(JP) Gnanam
  Company: Lean Six Sigma Experts



*** NREL, Golden, CO: Undergraduate Intern, Quality Management ****
Posting Title Internship- Quality Management 
Requisition Number 1910BR 
Location Golden, CO 
Position Type Student RPP 
Hours Per Week 40 
Job Duties 
- Student internship is available in the Quality Management Systems & 
    Assurance Office at the National Renewable Energy Laboratory (NREL) in 
    Colorado. NREL is the nation's primary laboratory for research, 
    development and deployment of renewable energy and energy efficiency 
    technologies. 
- The purpose of this summer internship is to provide meaningful 
    professional quality management experience to students with proven 
    academic performance and a strong desire to learn and contribute. The 
    Quality Management Systems & Assurance (QMS&A) department provides the 
    quality infrastructure, procedures, processes, training, and support 
    which facilitate a quality culture to promote continuous improvement at 
    NREL. In addition to quality management the summer internship will 
    provide exposure to document control and records management best 
    practices under the guidance of the Records Program Manager. The intern 
    will assist a dedicated staff to help accomplish this important 
    mission. 
- Specific responsibilities for the summer intern could include performing 
    work in research laboratories, construction areas, and other site 
    operations and facilities. Duties of the summer intern include these:
   - Collect and document basic process and operating information 
     consistent with ISO 9000 document control and records management 
     guidelines. 
  - Assist quality management experts in characterizing processes, 
    including development of process maps/flowcharts and operating 
    procedures consistent with ISO9001, ISO14001, and OHSAS18001.
  - Participate as a team member on quality assessments. 
  - Assist in developing components of the Quality Management System.
  - Assist quality management experts and/or other NREL personnel in 
    assessing the effectiveness and efficiency of processes (including the 
    use of continuous improvement methodologies).
  - Assist in developing recommendations for improving operations.
  - Assist in the development of software quality processes and operating 
    procedures; 
  - Provide a summary presentation at the conclusion of the internship 
    regarding the internship experience.
  - Perform other duties as assigned. 
- Required Education and Experience Must be enrolled as a full-time 
    student.
- Undergraduate students enrolled in a minimum of twelve credit hours.
- Graduate students enrolled in a minimum of nine credit hours.
- Minimum of a 3.0 grade point average in the last completed semester.
- Must be a United States citizen or permanent resident. 
Additional Required
- Knowledge, Skills and Attributes Completion of 3 years or more in an 
    accredited university in a quality management curriculum or a 
    discipline related to quality management (such as industrial 
    engineering, systems engineering, software quality assurance, business 
    management, operations research, or management science).
- Some prior knowledge and experience with quality management methods and 
    continuous improvement technologies such as TQM, Lean Enterprise, or 
    Six Sigma.
- Some prior knowledge and experience with ISO 9001, ISO 14001, ISO 17025, 
    OHSAS 18001, Capability Maturity Model Integrated (CMMI) and/or related 
    quality management & quality assurance standards.
- Some prior knowledge and experience with document control and records 
    management procedures.
- Excellent interpersonal skills. Excellent verbal and written 
    communication skills.
- Ability to perform duties with minimal supervision.
- Familiarity with Microsoft Office (including Visio), Microsoft Outlook, 
    Microsoft SharePoint. 
- EEO Policy / E-Verify NREL is an Equal Opportunity/Affirmative Action 
   Employer and provides equal employment opportunities to all qualified 
   persons without regard to race, age, color, sex, religion, national 
   origin, marital or veteran status, or any other legally protected 
   status.
- NREL validates right to work using E-Verify. NREL will provide the Social 
   Security Administration (SSA) and, if necessary, the Department of 
   Homeland Security (DHS), with information from each new employee's Form 
   I-9 to confirm work authorization. For additional information, please 
  see NREL EEO policy
Persons interested apply on-line at NREL employment via search job link 
with Requisition Number: 1910BR


                       Apr 2011 - Jobs Postings

Mid Apr 2011 email


*** QA Manager, Emerson Process Management, Boulder, CO ****
Emerson Process Management (www.emerson.com) is a leader in helping 
  businesses automate their production, processing and distribution in the 
  chemical, oil and gas, refining, pulp and paper, power, water and 
  wastewater treatment, metals and mining, food and beverage, 
  pharmaceutical and other industries. A division of Emerson, Rosemount DP 
  Flow is a global leader in high-precision pressure, temperature, level, 
  and flow instrumentation.
- We have a QA Manager position available at our Boulder facility.
- It is a full time position, Monday - Friday.  
Job Description:
Supervision, leadership & planning of quality department and all worldwide 
  quality related functions, including but not limited to:
- Oversee, maintain, and improve the company's ISO 9001:2008, ASME, and 
    European Pressure Equipment Directive programs. 
- Assume the responsibility of ISO Representative, coordinate and lead or 
    participate in third party quality audits, inclusive of schedules, 
    communication, reports and tracking follow-up actions. 
- Maintain and administer all supporting corporate procedures and policies. 
- Oversee and champion the Corrective Action system.  Maintain the 
    corrective/preventive action program, inclusive of tracking status of 
    open actions, receiving and reviewing responses, working with 
    departments for timely completion and periodic reports and metrics. 
- Identify system-wide root causes using problem solving tools such as 
    process flows, fishbone diagrams, process and product FMEA’s, control 
    plans, and control charts.  
- Work with department managers and teams to predict defects and complaints 
    then develop and implement solutions to improve. 
- Supports and acts as advocate for continuous improvement by utilizing 
    lean manufacturing techniques, Kaizen principles, statistical process 
    controls and other quality tools. 
- Establishes key performance indicators and maintains systems for 
    tracking, reporting and improving performance.  
- Training and empowering all employees to participate in continuous 
    improvement activities. 
- Active involvement in Six Sigma projects as they relate to quality 
    assurance and associated customer satisfaction issues. 
- Setting QA compliance objectives and ensuring that targets are achieved; 
    Monitoring performance and quality system trends.  
- Keeps Senior Management and Global Quality Teams aware of any significant 
    Quality trends or concerns on a monthly basis and holds the Monthly 
    Management Review.  
- Participate on global quality leadership teams to develop and implement 
    world-wide procedures and processes and to share best practices. 
- Staffs, directs and develops the QA team
- Is part of the Management Leadership Team for Rosemount DP Flow, helping 
    to formulate and administrate site policy, strategies, and processes
Requirements: 
- Bachelor’s Degree in Engineering required, MBA a plus
- At least 5 years of experience in Quality Assurance, should be combined 
    with a demonstrated track-record of accomplishments in a QA Leadership role
- Certified by ASQ (American Society for Quality) as a CQE/QC Mgr preferred
- Experience in a manufacturing environment
- Strong analytical skills and proficient in data collection and 
    presentation
- Exceptional oral and written communication skills
- Formal Six Sigma Certification is desirable
- Ability to take initiative, provide leadership, maintain confidentiality, 
    meet deadlines and work in a team environment
Interested individuals can apply on Emerson’s career page or can click here



*** Intern Undergraduate, NREL, Golden, CO ****
Intern Undergraduate- Performance Management & Analysis 
Requisition Number 1945BR
Location Golden, CO
Job/Research Summary
A student internship is available in the Performance Management & Analysis 
  Team (PM&A) at the National Renewable Energy Laboratory (NREL) in Golden, 
  Colorado. NREL is the nation's primary laboratory for research, 
  development and deployment of renewable energy and energy efficiency 
  technologies. The position would be temporary full time during the summer 
  internship.
Job Duties: 
- The purpose of this summer internship is to provide meaningful 
    professional data analysis and process improvement experience to 
    students with proven academic performance and a strong desire to learn 
    and contribute. The PM&A Team provides data collection; analysis and 
    dashboard display of critical laboratory operational metrics. The PM&A 
    Team also leads and mentors process improvements in the laboratory 
    using industry standard tools and methods. The intern will assist a 
    dedicated staff to help accomplish critical  tasks related to these 
    important missions. 
- This position will work under close supervision and guidance to perform 
    basic day-to-day support functions. Contacts are typically within the 
    Center /Office and occasionally with external contacts. Contacts 
    involve obtaining or providing information or data requiring some 
    explanation or interpretation.
- This position will perform clearly defined, short-duration tasks and 
    activities in support of the PM&A Team goals and objectives including:
  - Participate in data collection and analysis activities to include some 
      basic statistical analysis.
  - Meet with Center / Office Director level and below to interpret data 
      and teach the analysis mechanics.
  - Create KPIs and more detailed graphs and charts which describe the data 
      in a meaningful way to the identified audience.
  - Participate in process analysis and development activities to include 
      recording process flows and associated measurements.
  - Participate in process improvement activities to potentially include 
      problem identification and definition, root cause analysis, solution 
      identification, implementation and measurement.
  - Create standard reports, documentation, and records of simple nature.
  - Present / co-present specific expertise in process or data analysis to 
      cross functional audiences consisting of 15 - 50 individuals.
  - Assist in developing recommendations for improving operations. 
  - Provide a summary presentation at the conclusion of the internship 
      regarding the internship experience.
  - Perform other duties as assigned.
Required Education and Experience
- Must be enrolled as a full-time student.
- Undergraduate students enrolled in a minimum of twelve credit hours.
- Graduate students enrolled in a minimum of nine credit hours.
- Minimum of a 3.0 grade point average in the last completed semester.
- Must be a United States citizen or permanent resident.
- Additional Required Knowledge, Skills and Attributes
- Intermediate skills in data analysis, statistical modeling and technical 
    skills (programming, scripting, and statistical package skills - 
    MiniTab, SAS, etc.).
- Basic task and time management skills. Proficient in written/verbal 
    communications.
- Very good team collaboration and interpersonal skills with an incredible 
    zeal to learn new skills.
- Ability to perform duties with minimal supervision.
- Familiarity with Microsoft Office (including Visio) , Microsoft Outlook, 
- Microsoft SharePoint. 
Preferred Qualifications 
- Completion of three years or more in an accredited university in a 
    business administration, statistics, applied mathematics, information 
    technology or related degree program (such as industrial engineering, 
    systems engineering, business management, operations research, or 
    management science).
Persons interested apply on-line at NREL employment job openings
via Search Openings link with Requisition Number: 1945BR



*** Executive Director, NREL, Golden, CO ****
Executive Director - Environment, Health, Safety, Security and Quality
Requisition Number 1981BR
Location Golden, CO
Job Summary
- The National Renewable Energy Laboratory (NREL) located at the foothills 
    of the Rocky Mountains in Golden, Colorado is the nation’s primary 
    laboratory for research, development and deployment of renewable energy 
    and energy efficiency technologies. NREL has an opening for the 
    position of Executive Director - Environment, Health, Safety, Security 
    and Quality.
- The successful candidate will be a strong strategic thinker with 
    demonstrated success in leading the environmental, health, safety 
    security and quality functions for a high tech, utility, research and 
    development, or manufacturing organization.
- Full relocation package will be provided.
Job Duties 
Role Description:
- Works proactively with management and staff across the Lab to foster 
    continuous improvement and shape behavior in safety and environmental 
    protection before incidents occur. 
- Serves as corporate resource in providing technical assistance, 
    coordination, and integration in the resolution of safety and 
    environmental issues. 
- Provides high-quality, customer-focused assistance that enables improved 
    program and field implementation of safety and environmental 
    protection.
- Identifies Lab-wide safety and environmental protection assistance needs 
    and opportunities. Leads efforts to identify assistance needs, 
    prioritize assistance activities, and resolve issues through direct 
    interface with customers and stakeholders. 
- Serves as the Lab’s resource for interpretation and guidance on existing 
    and emerging external environmental regulations on hazardous waste 
    management and site cleanup (RCRA; CERCLA), pollution prevention and 
    electronics stewardship, toxic chemical inventory reporting, cultural 
    and natural resource protection (air, water, and biota), as well as 
    hazardous substance release response.
- Assists in the development and delivery of compliance training and risk 
    assessment tools to support Lab operations, cleanup, and long-term 
    stewardship. 
- Manages activities to develop, promulgate, and maintain worker safety and 
    health policy. 
- Maintains liaison with regulatory agencies with respect to worker safety 
    and health matters. 
- Provides management oversight and direction NREL security operations, 
    including physical protection, and operational security.
- Directs Lab-wide emergency response activities associated with 
    operational emergencies and emergency assistance situations. 
- Directs investigations of alleged or suspected acts against NREL 
    facilities impacting national security, personnel security, compromise 
    of classified or sensitive information, as well as violations of 
    applicable laws.
- Provides technical support to NREL in understanding how to implement 
    internal and external QA requirements. 
- Identifies Lab-wide quality assurance assistance needs and opportunities. 
    Prioritizes assistance activities and resolves issues through direct 
    interface with customers and stakeholders.
Required Education and Experience 
- Previous management and budget administration experience required. 
- Program strategy, development and implementation experience required. 
- Degree in appropriate field may be required.
- Required Knowledge, Skills and Attributes Extensive knowledge of the 
    renewable energy industry, as appropriate, as well as regulations, 
    principles, procedures and practices of relevant discipline(s).
- Solves variety of multi-dimensional problems in absence of guidelines or 
   precedents.
- Models and embeds NREL values. 
- Keeps abreast of key issues affecting respective Center/Office industry 
    discipline(s).
- Builds effective teams; creates strong morale and spirit; shares wins and 
    successes.
- Demonstrated ability to effectively lead and direct personnel with 
    diverse skills, work styles and values, both directly and through 
    subordinate management.
Additional Required Knowledge, Skills and Attributes
- The successful candidate will have a background that includes a minimum 
    of 15 years of relevant work experience as evidenced by the following:
- Critical:
  - Established record working with all levels of an organization, 
    including senior leadership.
  - Demonstrated ability to apply a broad knowledge and understanding of 
      the following disciplines:
      - Environmental
      - Health
      - Safety
      - Security
      - Quality
  - Demonstrated ability to apply seasoned business judgment to related 
      issues and advise on appropriate solutions.
  - Proven leadership with strong problem-solving aptitude and ability to 
      plan and meet fiscal objectives.
  - Demonstrated thorough understanding of Laboratory management, financial 
      planning and interdisciplinary laboratory applications. 
  - Successful track record involving business and organizational planning, 
      coordination and execution.
  - Demonstrated leadership, organizational and planning skills to 
      accomplish task assignments within stringent deadlines and often with 
      limited lead time.
  - The successful candidate will be subject to a U.S. government security 
      investigation and must meet eligibility requirements for access to 
      classified information. In order to meet the government security 
     investigation requirements, U.S. citizenship is a prerequisite.
Travel Requirements:
- Extensive travel will be required based on business need.
Personal Attributes:
- Strong leadership skills.
- Strategic thinker.
- Strong business and financial acumen.
- Strong sense of integrity and trust and the ability to respond with 
    flexibility and adaptability in response to business demands. 
- Demonstrated capability to analyze, synthesize, and integrate information 
    to effectively identify and solve problems.
- Demonstrated ability to identify and work under firm deadlines and 
    multiple ongoing tasks.
- Demonstrated ability to identity and pursue opportunities, takes prudent 
    risks and assume responsibility in the face of uncertainty or 
    challenges.
- Strong attention to quality. 
- Creativity.
- Interpersonally savvy.
- Demonstrated managerial courage.
Education: 
- Bachelors degree at minimum plus a minimum 15 years related experience 
    and/or training is required.
- Preferred Qualifications Masters degree or equivalent preferred.
Persons interested apply on-line at NREL employment job openings
via Search Openings link with Requisition Number: 1981BR


                       Mar 2011 - Jobs Postings
End Mar 2011 email


*** Senior Quality Engineer, Medical Devices, Boulder (Gunbarrel), CO ****
Senior Quality Engineer 
Mountainside Medical, LLC located in the Boulder CO area is a progressive 
  high-end manufacturer of medical devices and instrumentation for 
  specialized surgical and orthopedic industries. Currently, we are looking 
  to add a senior level Quality Engineer to our team. 
Description: 
  The Sr. Quality Engineer is expected to interact with customers, and 
  provide support for Production, Engineering and Quality. The successful 
  candidate will also assist in the design and implementation of 
  measurement methods (MSA), Control Plan initiation, and statistical 
  analysis and reporting throughout the development and launch of products. 
Duties include but are not limited to: 
- Creates and assists in the execution of validation protocols 
- Conducts process validations/Gage R&R 
- Authors procedures and incoming inspection reports 
- Develops and proves out measurement methods for new products 
- Assists with First Article, In-Process and Final Inspections as needed 
- Actively participates in internal audits 
- Performs process development activities 
- Assists in the compilation of reports for monitoring of company metrics 
- Tracks Quality issues and implements suggested improvements 
Requirements include but are not limited to: 
- B.S. in Engineering field or related technology 
- 5+ years of experience 
- Must have preventive and corrective action knowledge (8-D, 5-Why, etc.) 
- Strong math and statistical skills 
- In-depth working knowledge of GD&T 
- Microsoft Word and Excel proficiency is a must 
- Understanding of process validations in medical manufacturing 
- Excellent written and verbal communication skills 
- Experience in an ISO 13485 certified facility a plus 
- Experience with machining and mechanical assembly a plus 
To apply submit cover letter, resume and salary history 
  with subject: Senior Quality Engineer to Jobs at Mountainside Medical


Early Mar 2011 email


*** ISO 9000 Internal Auditor Trainee, Cavendish Scott, Inc, Denver, CO ****
Cavendish Scott, Inc. is looking for a trainee internal auditor.
- This is a trainee position rather than one for a fully qualified auditor 
    as we want to develop our new colleague in our unique philosophy and 
    style.
- Cavendish Scott is the industry leader in providing ISO management system 
    consulting.
- We provide the most practical, business focused and ethical systems to 
    meet our customers’ needs.  
- See Cavendish Scott Web for more company information.
Description:
- The role includes conducting internal audits to ISO 9001 and other 
    similar standards (AS 9100, 14001, 13485, 17025, etc.) for 
    Cavendish Scott clients.
- Initially you will be part of an audit team and provided full support.
- You will be given comprehensive formal and on the job training and 
    eventually you will audit independently and lead audit teams.
- The role will allow development as a professional ISO auditor, 
    fully and formally qualified and performing and leading audits
    in a variety of standards.
- It is hoped that you will also participate in the provision of ISO 
    training courses and possibly present training classes independently.
- The ideal candidate will be dynamic, self-motivated, well presented,
    a good communicator, capable of working alone, capable of individual 
    development and free to travel easily for about 0-10 days per month. 
- You will be familiar with Microsoft office and outlook email.
- You will probably be an ISO (or similar) internal auditor, possibly
   full time but possibly as an occasional auditor in addition to your 
   other duties.  
Remuneration includes a generous salary package, bonuses, health,
  dental, vision and 401k contributions.
To apply please briefly outline your applicability 
  - the above criteria along with 
  - Your recent work history and salary requirements.
  - Your experience of and knowledge of ISO 9000 (or similar standards e.g. FDA)
  - Your auditing experience
  In an email to apply at Cavendish Scott, Inc


*** Reliability Engineer, Renewable Energy - Colorado ****
Shanklin & Associates is looking to add a system level Reliability Engineer 
  who will be a key member of the Product Development team responsible for 
  ensuring the outgoing quality and reliability performance of products 
  supported through systematic reduction, elimination and control of 
  potential product and system failures.
They will develop requirements to screen infant mortality and workmanship 
  defects for near-term quality including but not limited to Highly 
  Accelerated Stress Screening (HASS) and Burn-In Screening.
They will be required to create and execute a Development strategy for 
  long-term reliability that includes: 
- Design for Reliability - Parts Management, Stress Analysis, Margin and 
    Tolerance Analysis, FMEA, Fault-tree Analysis 
- Reliability Modeling 
- Reliability Verification/Improvement Testing - HALT, Life Test, 
    Reliability Growth Test 
Requirements: 
- Advanced Degree in a relevant Engineering discipline, PhD preferred 
- 8 + years of relevant Reliability support of design/development team 
    and/or existing product platforms 
- Proficiency at computing Reliability measures such as population  
    distributions, failure rates, and MTBF 
- Understanding of physics of failure for IGBTs, FETs, solder joints, high 
    power connections 
Shanklin & Associates is a Talent Acquisition firm that focuses on 
  recruiting technical talent.
Joy Shanklin, the President of Shanklin & Associates, is a degreed 
  Electrical Engineer from Ohio State University and has over 10 years of 
  experience as an engineering professional. This has proved to be of 
  tremendous value to both our clients and candidates that we work with. 
For Questions, more information and applying (cover letter, resume) 
  email with subject: Reliability Engineer
 to job at Shanklin & Associates
For other open positions see: Shanklin & Associates web site


                       Feb 2011 - Jobs Postings
Middle Feb 2011 email

*** Quality Engineer, Englewood, CO ****
Boecore Professional Solutions, LLC (BPS) is a wholly owned subsidiary of 
  Boecore Inc., a woman owned small business headquartered in Colorado 
  Springs, Colorado. BPS specializes in staffing solutions for our 
  government and commercial customers. At BPS, we seek professionals 
  who demonstrate commitment and excellence in their field.
We offer a team-based environment where each individual can contribute 
  to our success and rapid growth. We offer competitive salaries, health 
  benefits, and rewarding work environments with a proven record of 
  success.
We are seeking a Quality Engineer who is able to be involved with all 
  program decisions pertaining to Quality Assurance from the initial 
  Statement of Work through final delivery of the product. This candidate 
  will actively work the processing of DPA and other component testing per 
  contract requirements. 
The Quality Engineer will 
- Oversee implementation of shop order travelers to ensure compliance to 
    contractual and engineering requirements. 
  Processes all non-conformances through final resolution, which may 
    include any MRB/FRB actions, supplier issues, and cause and corrective 
    action. 
  Also acts as an interface between the customer and Client. 
  The candidate will review and approve all engineering and shop order 
    traveler changes that may be encountered through build process. 
  Will provide support for inspection personnel in the area of problem 
    resolution. 
  The Quality Engineer will review and participate in all acceptance level 
    testing per contract requirements. 
  The candidate will compile all documentation throughout the build process 
    for End Item data package, and assist manufacturing personnel during 
    implementation of process changes. 
EXPERIENCE/EDUCATION/REQUIREMENTS: 
  A minimum of 5 years of experience in Quality Assurance Engineering with 
    an aerospace background is required. 
  A Bachelor's degree is required. 
  The Quality Engineer must have full knowledge of Quality Systems, such as 
    AS9100. 
  Must have a solid understanding of non-conformance resolution and 
    corrective action implementation. 
  Strong understanding of electronic and mechanical engineering drawings 
    and environmental testing of electronic assemblies is preferable. 
  The candidate must be able to use a PC, including Microsoft Office tools 
    such as Word, Excel, PowerPoint, and Access.
No Relocation No Third Parties 
For Questions, more information and applying (cover letter, resume) 
  email with subject: Reliability Engineer
  to to Heather Harvey 
or apply directly on-line at Boecore Professional Solutions


*** Reliability Engineer, Denver, CO ***
We are looking to add a Reliability Engineer who will be a key member 
  of the Product Development team responsible for ensuring the outgoing 
  quality and reliability performance of products supported through 
  systematic reduction, elimination and control of potential product and 
  system failures.
They will develop requirements to screen infant mortality and workmanship 
  defects for near-term quality including but not limited to Highly 
  Accelerated Stress Screening (HASS) and Burn-In Screening.
They will be required to create and execute a Development strategy for 
  long-term reliability that includes: 
- Design for Reliability - Parts Management, Stress Analysis, Margin 
    and Tolerance Analysis, FMEA, Fault-tree Analysis 
- Reliability Modeling 
- Reliability Verification/Improvement Testing - HALT, Life Test, 
    Reliability Growth Test 
Requirements: 
- Advanced Degree in a relevant Engineering discipline, PhD preferred 
- 8 + years of relevant Reliability support of design/development team 
    and/or existing product platforms 
- Proficiency at computing Reliability measures such as population 
    distributions, failure rates, and MTBF 
- Understanding of physics of failure for IGBTs, FETs, solder joints, 
    high power connections 
Shanklin & Associates is a Talent Acquisition firm that focuses on 
  recruiting technical talent.
Joy Shanklin, the President of Shanklin & Associates, is a degreed 
  Electrical Engineer from Ohio State University and has over 10 years of 
  experience as an engineering professional.
This has proved to be of tremendous value to both our clients and 
  candidates that we work with. 
For Questions, more information and applying (cover letter, resume) 
  email with subject: Reliability Engineer to Jobs at Shanklin & Associates


*** Quality Engineer, Medical Devices, Boulder (Gunbarrel), CO ****
Rapidly growing Medical Device contract manufacturer is looking for 
  a Quality Engineer to add to our team. 
Duties include but are not limited to: 
- Writes validation protocols and creates reports; 
- Conducts in-process validations and Gage R&R; 
- Writes procedures and incoming inspection reports; 
- Files quality documentation; 
- Performs inspections when needed; 
- Maintains calibration system of inspection equipment; 
- Programs and qualifies automatic measurement programs utilizing 
    Smart scope and CMM; 
- Compiles reports of monthly quality related company metrics; 
- Tracks quality issues and implements suggested improvements or 
    inspection controls; 
- Conducts supplier and internal audits. 
Requirements include but are not limited to: 
- Strong understanding of manufacturing processes and validation; 
- Math and statistics skills, preferably using MiniTab; 
- Effective communication skills both oral and written; 
- Computer proficiency using Microsoft word and excel; 
- Working knowledge of process validations in manufacturing; 
- BS or equivalent combination of experience and education; 
- Skill in ISO certification; 
- Six Sigma training a plus; 
- Skill in a medical device manufacturing environment strongly preferred. 
Work is performed in a machining environment. 
To apply submit cover letter, resume and salary history 
  with subject: Quality Engineer to Jobs at Mountainside Medical

Early-Feb 2011 email


*** CMM Programmer, Medical Devices, Boulder (Gunbarrel), CO ****
CMM Programmer - Gunbarrel - Medical Devices 
Duties include, but are not limited to: 
- Performs precision measurement using technical skills to create 
    inspection programs for coordinate-measuring machines.
- Performs as data gatherer, analyst and reporter, using custom-written 
    programs to generate inspection data for manufacturing, engineering, 
    quality and customers. 
- Interprets geometric dimensioning and tolerancing (GD&T) frames from 
    blueprints and uses mathematical data.
- Translates data into inspection program output to ensure manufactured 
    products meet internal engineering and customer dimensional 
    specifications. 
- Collects data in printed and electronic format and performs analysis and 
    reporting regarding the collected data. 
- Reports dimensional, statistical, capability and measurement system data 
    in a variety of formats. 
- Ability to interpret and explain CMM results to production and 
    engineering staff in a clear, concise manner. 
- Analyses raw inspection data and exports this data into the desired 
    format. 
- Performs reverse engineering functions, taking existing products and 
    transforming them, via scanning or other programming methods, into
    electronic data for engineering or manufacturing use. 
Requirements include, but are not limited to: 
- Skill in programming CMM using Calypso 
- Skill in programming multi-axis machines 
- Skill in holding to tight tolerances 
- Skill in calculating numbers and apply concepts of algebra, geometry, 
    and trigonometry 
- Skill in reading blueprints 
- Knowledge of GD&T 
- Knowledge of inspection techniques and equipment such as calipers, 
    micrometers, optical comparators, and others 
- 5 years of experience working in a Quality Assurance position 
- Ability to establish effective relationships with internal and external 
    customers 
- High school diploma or equivalent 
- ISO 13485 experience is a plus 
- Medical device experience is highly preferred 
Very clean work environment; standing and sitting; working with computer. 
To apply submit cover letter, resume and salary history 
  with subject: CMM Programmer to Jobs at Mountainside Medical



*** Sr. Quality Engineer, Covidien, Boulder (Gunbarrel), CO ****
POSITION TITLE: Sr. Quality Engineer 
DEPARTMENT: Quality Assurance
BUSINESS UNIT: Respiratory
REPORTS TO: Quality Engineering Manager
SUMMARY OF POSITION:
- Provide quality engineering support in design and development of medical 
    device products, and facilitate the application of design controls.
- For more Covidien information, visit us as www.covidien.com  
ESSENTIAL FUNCTIONS:
1 Review new and modified product designs for quality characteristics, 
  including manufacturability, serviceability, testability, reliability, 
  and conformance to product requirements.
2 Ensure that product development projects and changes to existing 
  products are conducted in compliance with the FDA Quality System 
  Regulation.
3 Ensure successful transfer of new products to production facility. 
  Review production processes for quality of validation.
4 Review and approve verification and validation test plans. Ensure 
  verification results demonstrate compliance to medical device standards.
5 Provide training to project teams on verification/validation 
  statistical methods and design controls.
6 Lead product risk assessment efforts within product teams.
7 Review Design History Files and Technical Files for conformance to 
  applicable requirements.
8 Provide Quality support to facilitate the rapid resolution of product 
  complaints and/or safety issues.
9 Conduct internal quality system and supplier quality audits.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
- Education: BS or MS in an engineering discipline 
- Experience: 5+ years of quality engineering experience
- Skills/Competencies: Working knowledge of and auditing experience to the 
    FDA Quality System Regulation, ISO 13485, and the Medical Device 
    Directive.
- Experience with test methods and standards for the design, verification, 
    and validation of medical device products.
- Skilled in test plan development and root cause failure analysis.
- Skilled in statistical methods, including ANOVA, statistical process 
    control, sampling plans, gauge R&R, and design of experiments.
- Good verbal (including presentation) and written communication skills, 
    especially technical report writing. 
- Ability to effectively work on project teams.
  Preferred Skills/Qualifications: Familiar with reliability analysis and 
    test methods.
- Familiar with ISO 14971. Experience in risk evaluation techniques, such 
    as FMEA, fault tree analysis or HACCP.
- Manufacturing engineering or manufacturing quality engineering experience 
    preferred.
- ASQ CQE or CRE certification.
- Other Skills: Spanish proficiency desirable
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
- Will be working in cross-functional teams as the Quality System expert.
WORKING CONDITIONS:
- Normal office conditions.  Up to 10% travel required
To apply submit cover letter and resume on at 
  Covidien jobs
  click on link "Search US Positions by State"
  then on "CO" for Colorado jobs


**** DONE with ASQ Section 1313 Job Postings ***** 


Section 1313 Web Page ASQ 1313 Section

Section 1313 E-mail Section Info