ASQ Section 1313 Boulder, CO Date: 12 Aug 2010
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
Aug 2010 - Jobs Postings
Mid Aug email:
*** Genesee BioMedical, Denver, CO: QA Technician/Inspector
Genesee BioMedical, Inc. a world-class manufacturer of cardiac surgery
instruments and devices has an immediate opening for a Split or 2nd Shift
Quality Assurance Technician/Inspector.
Person applying must have attention to details and work independently with
minimal supervision.
Position Title: QA Technician/Inspector
Responsibilities:
Preferred Education and Work Experience Qualifications:
- Minimum of 2 to 3 years combined experience in quality and manufacturing.
- Good understanding of standard quality control/ quality assurance
methods.
- High School diploma or equivalent and work experience in a quality
related field.
Familiar with MS Word helpful
Position Objectives:
- Entry Level Position
- Perform QA and regulatory support activities.
- In Process and Incoming Materials Inspecting
- Work In clean room environment
- Maintain systems related to quality assurance and regulatory compliance.
Persons interested send your Resume, Cover letter and Salary History with
subject "job: QA Technician/Inspector" to email: Genesee BioMedical, QA Dept
or via US-Mail:
Genesee BioMedical, Inc.
Attn: QA Dept.
1308 South Jason Street
Denver, CO 80223
*** Genesee BioMedical, Denver, CO: QA Lead Inspector/Supervisor
Genesee BioMedical, Inc. a world-class manufacturer of cardiac surgery
instruments and devices has an immediate opening for a Split or 2nd Shift
Quality Assurance Lead Inspector/Supervisor.
Person applying must have attention to details and work independently with
minimal supervision.
Position Title: QA Lead Inspector/Supervisor
Responsibilities:
- Supervise and schedule duties of Split or 2nd Shift QA staff.
Preferred Education and Work Experience Qualifications:
- Minimum of 3 to 5 years combined experience in quality and manufacturing.
- Familiarity with quality assurance methods and techniques;
- Attention to detail;
- Familiarity with FDA and ISO requirements.
- Supervisory experience helpful.
- High School diploma or equivalent and work experience in a quality related field.
- Familiar with MS Word helpful
Position Objectives:
- Perform QA and regulatory support activities.
- In Process and Incoming Materials Inspecting
- Work In clean room environment
- Maintain systems related to quality assurance and regulatory compliance.
Persons interested send your Resume, Cover letter and Salary History with
subject "job: QA Lead Inspector/Supervisor" to email: Genesee BioMedical, QA Dept
or via US-Mail:
Genesee BioMedical, Inc.
Attn: QA Dept.
1308 South Jason Street
Denver, CO 80223
*** Contract Engineering Services, Denver, CO: Quality Engineer Associate
- Bachelor’s degree in a technical discipline or equivalent experience.
- Minimum related work experience of 3 to 5 years in Class II/III medical
device manufacturing.
- Must have proven proficiency in problem analysis, testing and laboratory
skills.
- Ability to work within a changing environment.
- Ability to work together with a wide variety of personnel on all levels
and utilize constructive confrontation techniques when faced with
challenging issues.
- ASQ Certified Quality Engineer is a plus
- Statistics knowledge
- Knowledge of regulatory requirements (e.g., FDA, ISO) as required for
the position.
- Possess methodical documentation skills
- Excellent presentation skills
- Able to communicate across functional lines
Persons interested send your Resume and Cover letter with
subject "job: Quality Engineer Associate" to email: Contract Engineering Services
email: mailbox@cesdenver.com
or for more information call Phone: 303-757-8500
Jul 2010 - Jobs Postings
Late Jul email:
*** Alliant National Title Insurance, Longmont, CO: CQA 1-day audit
Alliant National Title Insurance Company in Longmont is looking for a
Certified Quality Auditor as an independent source to do a 1-day
internal review and audit of their process to bringing on new
title agents.
The Auditor:
Will get process map and the application forms
Will walk through the process map to understand the process
Will sample applications files
Will write up report management
Time frame in Sep 2010
Persons interested please contact Paul Rost
phone: 303 817 0195
email: Paul Rost
*** Vestas, Brighton, CO Quality Manager ****
Power your life
Vestas offers you challenging career opportunities in a global
organization. As the world's leading supplier of wind power solutions
we have installed more than 39,000 wind turbines in 63 countries.
We are currently more than 20,000 employees, and we are eager to
welcome new dedicated colleagues. Care to join us
Company & Department
Vestas Nacelles America, Inc. / Brighton, CO
Quality Department
Responsibilities and Tasks
Plans, coordinates, and directs quality program designed to ensure
quality control and quality assurance of the production of products
consistent with established standards by performing the following
duties personally or through subordinate supervisors.
Safety Roles and Responsibilities
- Conduct Safety Walks on designated basis and record event and findings
in the Nacelles Safety Walks Database. Production Related - Monthly;
Admin - Quarterly
- Conduct one-to-one Safety Contacts with hourly Team members
- Assess task performance in regards to safety for subordinate management
- Review investigative reports and delegate appropriate resources for
mitigation efforts
- Begin meetings with a safety note or message
- Participate in Team Member HSE area checks on a periodic basis
Essential Duties and Responsibilities Other duties may be assigned.
- ISO9001 Management Representative
- PBU Quality deployment
- Quality principles-Q on the agenda
- Internal audits
- Customer audit handling
- Compliance with control plans through SPC and capability
- Budget accountability
- Compliance using PQA and product/process verification
- Support validation of changes in products and processes
- Competence validation
- Quality improvement project portfolio management on factory level
- Elimination of recurring product defects
- Ensure best practice sharing
- Formulates and maintains quality objectives complementary to corporate
policies and goals.
- Satisfy requirements to achieve ISO 9001 implementation as well as
maintaining such certification.
- Act in the capacity of "lead auditor" for the quality team.
- Implementation of maintenance of the Nacelles Management System.
- Interprets quality philosophy to key personnel in organization.
- Performs quality engineering reviews of design documentation for
compliance with stated requirements, including vendor quality manuals
and company quality records.
- Applies statistical process control (SPC) methods for analyzing data to
evaluate the current process and process changes.
- Reviews all data obtained during all quality control and quality
assurance activities to ensure consistency with company policies and
procedures.
- Keeps management team abreast of significant issues or developments
identified during quality activities and actions being taken to
improve the situation.
- Prepares and presents program information to the management team.
- Maintains a working knowledge of government and industry quality codes
and standards.
- Plays active role on quality management teams within organization.
- Designs and implements quality training programs to key personnel in
conjunction with managers.
- Investigates and adjusts customer complaints regarding quality.
Supervisory Responsibilities
- Manages approximately 10 employees in the Quality department.
- Responsible for the overall direction, coordination, and evaluation.
- Carries out supervisory responsibilities in accordance with the
organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training employees;
planning, assigning, and directing work; appraising performance;
rewarding and disciplining employees; addressing complaints and
resolving problems.
Qualifications and Work Experience
- 5 years experience managing 3 or more people as the senior quality
official in an electronics or automotive manufacturing setting
- Six Sigma Green Belt
- Bachelors degree in business, operations, or related discipline
- ISO 9001 Experience
- Knowledge of calibrated tools (mechanical and electrical)
Preferences:
- Six Sigma Black Belt
- Certified Lean Master
- ASQ certified
What we offer
Vestas offers outstanding employee benefits including: 4 weeks annual
vacation accrual, 100% paid insurance premiums for employee and family
including medical, dental, vision, prescription; 100% paid premiums for
life, ADD and LTD; 401k with company match, and global opportunities
for training and development.
Persons interested please email resume and cover letter to Gary Held
*** NREL, Golden, CO: Sr QA Specialist I - SQA ****
Posting Title: Sr QA Specialist I - SQA
Requisition Number: 1442BR
Location: Golden, CO
Position Type: Regular Employee
Hours Per Week: 40
Job/Research Summary:
- The primary purpose of the Software Quality Assurance (SQA) role is to
define, document, implement, and manage NREL’s SQA Program to support
a dynamic and evolving range of research and business application
systems running on diverse platforms.
- The SQA Program consists of the systems, processes, and tools needed to
effectively implement SQA at all levels including organizations,
projects, and initiatives.
- This is a senior level position that works directly with Product Line
Managers, Project Managers, Line Managers, and others to determine the
applicability and deploy SQA Program requirements.
- The SQA Program includes all activities associated with software
development (e.g., requirements management, planning, design,
configuration management, testing, documenting, continuous improvement,
SQA assessments, etc.).
- The program will be based on existing industry consensus standards such
as the CMMI for Development and ISO 9001.
Job Duties
- Develop, implement, and manage a systematic approach to SQA including the
development of applicable policies, procedures, standards, and best
business practices that meet the requirements of NREL, federal, state,
and international consensus standards for in-house developed and COTS
software.
- Maintain an inventory and conduct risk assessments for in-house developed
software applications with an emphasis on safety control systems.
- Serve as technical resource and subject matter expert for software system
developers on SQA functions.
- Train software development staff in the use and application of applicable
SQA methods and tools.
- Consult with individuals to establish effective SQA approaches for
individual projects.
- Support customers by helping to define and participate in acceptance
testing of systems prior to implementation.
- Serve as the Lab’s resource for defining, identifying, and interpreting
applicable requirements and best practices to be incorporated into
software development activities.
- Oversee software vendors/contractors to evaluate and monitor their SQA
programs and ensure that NREL requirements are met.
- Periodically monitor software products and active software development
projects to verify compliance with laboratory policies, procedures, and
standards to facilitate early detection of problems that could affect
the reliability, maintainability, availability, integrity, safety,
security, and/or usability of software products.
- Assist software developers in evaluating the quality of their outputs and
the risks to their projects.
Required Education and Experience Relevant
- Master's Degree and 7 years experience or equivalent relevant
education/experience.
Additional Basic Required Knowledge, Skills and Abilities
- BS/BA degree required in computer science, information sciences, or
related field or equivalent relevant experience.
- Minimum of 10 years relevant experience including at least 5 years of
recent experience implementing SQA in diverse development environments.
- Knowledge of and experience in software engineering is required (e.g.,
software requirements development/management, software design and
architecture, software coding standards, software testing, automated
software test frameworks, fault-tree analysis, software bug tracking,
software configuration management).
- Must have in-depth knowledge of software development methodologies such
as RAD, Scrum, Team SW Process, Extreme Programming, RUP, Agile, etc.
- Experience in SQA program or project management, policy and procedure
development, and performing SQA assessments.
- Must have experience in implementing SQA standards such as the CMMI-DEV.
- Ability to drive improvements across organizations and systems is
required.
- Excellent consultative, interpersonal, facilitation and communicative
skills are required and essential to successful job performance.
- Incumbent will work in an environment requiring initiative, independent
judgment, and decision making. The ability to cope with ambiguity and
use facilitation, team building, and coaching skills is also required.
Preferred Qualifications
- Relevant advanced degree and/or a certification in quality management
(e.g., CSQE), software engineering, or a related field.
- Experience applying software engineering and control principles in a
research environment.
- Experience in leading SCAMPI type appraisals.
- Knowledge of ISO 9001 quality standard and its application to software.
Persons interested apply on-line at NREL employment job openings
via Search Openings link with Requisition Number: 1442BR
Jun 2010 - Jobs Postings
Middle: Jun email:
*** Sorin Group, United States: Quality Engineer Associate ****
POSITION SUMMARY:
- Under normal supervision, assists in quality engineering and laboratory
management work to achieve and maintain the highest possible product
quality levels and regulatory compliance. Supports team efforts to
improve product quality and product complaint handling BU wide.
- Frequently uses and applies technical standards, principles, theories,
and concepts. Understands the company’s practices, policies, and basic
therapies and uses the knowledge effectively in its application.
- Assists in the monitoring and trending of product complaint quality data.
This includes developing and implementing systems for tracking,
analyzing, reporting and problem solving.
- Analyzes product complaints and ensures that systematic problem solving
methods are employed and results are properly documented.
- Interfaces with customers and sister companies on product complaint and
vigilance reporting matters
- Monitors and supports compliance to regulatory and company requirements.
- Assists in the preparation, filing and tracking of product MDRs to ensure
on-time reporting, completeness and high levels of regulatory
compliance.
- Coordinates and drives all aspects of product complaint handling for both
domestic and international manufactured products within the BU.
- Assist in managing Commercial QA Laboratory to GLP requirements and
providing guidance to laboratory personnel in product problem
investigations and complaint handling.
- Works with Human and Bovine blood and blood products.
- Offers recommendations and participates in efforts to improve product
quality, complaint investigations and customer feedback in order to
maximize customer satisfaction and service.
- Evaluates and implements protocols and methods for all aspects of product
complaint handling to ensure compliance with companies quality
standards and regulatory requirements.
- Uses ingenuity in analyzing product technical problems and development of
testing methodologies and/or protocols.
- Understands and implements FDA or other regulatory requirements as
necessary.
- Frequently seeks and uses information from other BU companies to improve
efficiencies and overall complaint closure times.
- Performs other related duties as required in support of company and
departmental objectives.
Education and Qualifications:
- Bachelor’s degree in a technical discipline or equivalent experience.
- Minimum related work experience of 3 to 5 years in Class II/III medical
device manufacturing.
- Must have proven proficiency in problem analysis, testing and laboratory
skills.
- Ability to work within a changing environment.
- Ability to work together with a wide variety of personnel on all levels
and utilize constructive confrontation techniques when faced with
challenging issues.
- Certified Quality Engineer is a plus
- Statistics knowledge
- Knowledge of regulatory requirements (e.g., FDA, ISO) as required for the
position.
- Possess methodical documentation skills
- Excellent presentation skills
- Able to communicate across functional lines
Persons interested apply on-line at: Quality Engineer Associate job
*** White Wave, Broomfield, CO: Statistician ****
SUMMARY
As part of the R&D team located in Broomfield, Colorado, the position is
responsible for applying statistical techniques to design and analyze
experiments and consumer tests, determine manufacturing processes
capabilities, evaluate and model new process technologies, and make
recommendations to the Organization based on data-based learnings.
He/she will also be responsible for coaching and developing the project
leaders to help plan research approaches and to become proficient in
design and analysis of experiments and statistical evaluations.
THE CANDIDATE:
- Should be very familiar with applied statistics including experimental
designs, statistical process control, statistical data analysis, and
process modeling.
- Would have experience supporting product and process developers, in an
R&D organization, to design and analyze experiments and research
approaches.
- Would have experience working with Sensory and/or Consumer Insight groups
to design and analyze consumer test plans.
- Would be very well versed in using software (e.g. JMP/SAS, Mini-tab) to
design and analyze experiments, consumer tests, and analyze data.
- Should be a self starter, have strong personal leadership, and able to
work autonomously to plan, monitor, and deliver objectives.
- Would be a collaborative individual, and a strong R&D voice/leader within
G cross-functional setting, to influence program leaders and senior
management.
- Would be able to coach and develop others in R&D on how to use statistics
to advance their projects.
PRIMARY RESPONSIBILITIES:
- Ensure product/process/packaging developers are using designed
experiments and other statistical tools as part of their research
program approach.
- Develop and analyze designed experiments.
- Design and analyze consumer tests.
- Model capabilities of new technologies.
- Statistically evaluate existing manufacturing processes and recommend
improvement opportunities.
- Coach R&D organization to be come proficient in experimental design.
- Act as technical expert for the company.
MINIMUM QUALIFICATIONS
- Bachelor’s degree in Applied Statistics, Applied Mathematics,
or similar discipline.
- 5-10 years relevant experience in Fast Moving Consumer Packaged
Goods industry.
- Experience working directly with consumer products.
- Experience working in/with an R&D environment.
Persons interested apply on-line at: White Wave Statistician job
May 2010 - Jobs Postings
Middle: May email:
*** NREL, Golden, CO: Undergraduate Intern, Quality Management ****
Posting Title Undergraduate Intern, Quality Management
Requisition Number: 1238BR
Location: Golden, CO
Position Type: Student RPP
Hours Per Week: 40
Job/Research Summary:
- A student internship is available in the Quality Management Systems and
Assurance Office 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.
Job Duties
- A student internship is available in the Quality Management Systems and
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. 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;
- Assist quality management experts in characterizing processes,
including development of process maps/flowcharts and operating
procedures;
- 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; and
- Perform other duties as assigned.
Required Education and Experience:
- Must be enrolled as a full-time student (Undergraduate students minimum
of 12 credit hours or Graduate students minimum of 9 credit hours).
- Must be a US Citizen or US permanent resident.
- Minimum 3.0 GPA in the last completed semester.
Preferred Qualifications:
- 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.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
- Ability to perform duties with minimal supervision.
- Familiarity with Microsoft Office (including Visio) and Microsoft
Outlook.
Line Manager: Henry Higaki
Persons interested apply on-line at NREL employment via search job link
with Requisition Number: 1238BR
**** Food-Dairy, PA: Plant Manager ***
Position - Plant Manager - Food-Dairy
Location - Pennsylvania
Industry - Preference for Dairy-Food industry
Salary Package - Six figures, bonus, relocation package
Profit and Loss Responsibility - 8 figures (millions)
Education - Degree BS MBA strong preferred. Engineering (Mechanical,
Chemical, Manufacturing etc)
Experience - Lean Manufacturing Preferred. Certifications six sigma, ASQ,
APICS nice to have.
Position - full time and not consulting position.
Management experience involving - supervision and management
and hiring of plant staff
Regulatory knowledge such as FDA as well as standards regarding
processing/filling and general facility standards.
Personality - achievement oriented, goal oriented who has the
ability execute goals into action to achieve results.
Excellent communication skills and verbal skills.
Personality - motivated, goal oriented, ambitious, results oriented,
team oriented...a doer, a think ...man or woman of action
Analytical, problem solver, focus on high quality,
lower manufacturing costs
Experience with continuous improvement programs projects that focus
on quality, service, safety and performance.
Experience and knowledge regarding plant management practices with
major food companies in areas of manufacturing
logistics, and forecasting and food commodity markets.
Ability to improve cost and quality using lean practices.
Other Info: $2000 U.S referral fee offered subject to 90 probationary
period. Referral fee may be alternatively offered to a charitable
donation university of choice. Help a fellow American friend or
colleague know about this great job.
Persons interested. Please send resume to:
Josie Erent
Phone 416-232-0600
email: Josie Erent
**** Campus Management, Boca Raton, FL: Software QA Architect ***
Campus Management offers a range of career opportunities for professionals
in software development, project management, services and account
management, sales, marketing, finance, and other areas. The company seeks
talented, qualified professionals who share its core values of
excellence, innovation, and quality.
Title: Software QA Architect Job ID 94175
Location: Boca Raton - Corporate HQ
Job Description
- Our Quality Assurance Organization is looking for a Software Quality
Assurance Architect. He/she will report to the Director of Quality
Assurance at our HQ in Boca Raton, Florida. The successful candidate
will work closely with department leads from Development, Product
Support, Product Management and Project Management.
- Under the direction of the Director of Quality Assurance, the successful
candidate will help assist in the planning, coordination, and
implementation of quality assurance programs designed to ensure
continuous compliance to established policies and standards across the
different development organizations. Candidates must enjoy
project-based work and possess a positive and enthusiastic attitude.
Responsibilities:
- Provide team leadership in the areas of QA architecture
- Collaborate with Software Development Architects to implement methods
to design code for testability
- Develop new testing methods/techniques and mentor testers to be more
effective in exposing defects in the software.
- Develop metrics to measure product quality, in-process quality, and
maintenance quality.
- Collaborate with project managers to lead project quality assurance efforts.
- As assigned, serve as the quality liaison for various internal Process
Improvement Projects
- Monitor project’s and group’s adherence to the organization process
standards that incorporate industry best practices from CMMI, ISO,
Lean Development, etc.
- Support planning the organization process improvement and QA activities,
led by the corporate Quality Assurance Director
Qualification Requirements
- Any graduate or post graduate with 15+ years of experience in
Software Quality Assurance.
- Should have been involved in preparation of Quality Plan for projects.
- Excellent Verbal and written communication skills.
- Proficient on MS Excel
- Should be proficient with statistical analytical techniques
- Should have been involved in collection of project metrics and
analyzing project performance.
- Analyzing and compiling of Root cause Analysis for project and take
appropriate preventive action form its reoccurrence.
- Performs quality reviews and other control activities!
(e. g., participates in reviews of work products and processes)
to identify weak processes.
- Ensures employee training on quality issues
- Familiarity with Microsoft Visual Studio Team System 2008 Test Edition
and Test Load Agent is desired but not required.
- Proficient in writing C, C#, C++ or Java code for use in white box test
and automation strategies
- Proficient in SQL and able to create from scratch database queries
- Understanding of .NET and Linux computing environments
- Able to install and configure Windows .NET Server software (OS and
Applications) .NET and Linux Server software testing experience
- Excellent understanding of how code management, test coverage tools
and defect tracking tools are used
- Strong inter-personal and communication skills and comfortable in a
culturally diverse working environment; ability to interact positively
with management. Independent problem solving skills; self-motivated.
- Outstanding organizational and follow-up skills - detail oriented
and deadline driven
- Strong analytical skills with experience processing, analyzing
and summarizing data.
- Energetic, team-oriented, positive person who desires to work in a
fast-paced software development environment
Persons interested go to: Campus Managment careers site
Search for Title: Software QA Architect, Job ID: 94175 to apply
Apr 2010 - Jobs Postings
Middle: May e-mail:
**** Idaho Health Plan: Director, Business Process Management ***
POSITION PURPOSE:
To establish and direct a company-wide process improvement/reengineering
program by analyzing work processes and determining how work should be
arranged to maximize efficiency of the organization while minimizing
expenses.
MINIMUM POSITION REQUIREMENTS:
Required Experience:
- Five years in management of systems and business process analysis
and design
Required Education:
- Bachelor’s Degree in Business or Management
Required Knowledge, Skills and Abilities (KSAs):
Knowledge of:
- Business process management methodologies
- Process metrics, benchmarking, and mapping methodologies
- Change management
- Corporate level project management
- Business process management software applications
Ability to:
- Effectively work with, influence and lead business and technical users
- Communicate effectively with all levels of corporate management
- Discover and map process architecture
- Align processes with corporate strategy, business requirements, and
IT capabilities
- Manage high profile, corporate level projects
PREFERRED QUALIFICATIONS:
Knowledge of process management methodologies such as Six Sigma,
LEAN or other process management methodologies.
PRIMARY ACCOUNTABILITIES:
1. Business Process Architecture: Gather data about the organization’s
core and supporting processes and create and maintain the
organization’s process architecture documents
2. Process Mapping: Identify individual processes, gather process data,
and document the current-state-process
3. Process Requirements: Gather functional process data and determine and
document value-added process requirements
4. Process Analysis: Perform gap analysis and determine future state of
individual processes
5. Process Engineering: Work with business and technical personnel to
design new and redesign existing processes
6. Process Change: Create process change by integrating new processes
with existing ones
7. Change Management: Work with business personnel to effectively design
and implement the human side of process change
8. Process Tuning: Identify and incorporate metrics into processes that
will facilitate process improvement through specific ROI
9. Communication: Communicate process changes to impacted business systems
teams
10. Project Management: Lead re-engineering team and act as project manager
when needed
11. Systems: Make recommendations to management regarding the
implementation and configuration of business process management
software
MANAGEMENT ACCOUNTABILITIES:
1. Establish department objectives that support corporate goals and
produce regular status reports.
2. Prepare an operating budget that reflects the forecasted needs of
the department and control expenditures to assure adherence to
approved budgets.
3. Ensure effective workflows, maximize system efficiencies, monitor
quality performance measures and confirm appropriate completion of
work assignments. Make recommendations for change as appropriate.
4. Initiate personnel actions such as hiring, disciplinary, termination
and/or salary recommendations.
5. Participate in training, coaching and motivation of employees including
career path development. Assess individual employee performance and
conduct timely performance appraisals.
6. Promote teamwork, discussion, and cooperation among staff and other
departments. Ensure timely communication and sharing of information
with team members.
Persons interested email cover letter and resume to Molly Parsons
wth subject:
Job: Idaho Health Plan: Director, Business Process Management
Contact Molly Parsons at phone 757.652.1141 for additional information
Middle: Apr e-mail:
**** SQA Services, Louisville, CO: ten Quality Engineers ***
SQA will provide Managed Quality Engineering Services to our customer
at a facility in Louisville, Colorado. SQA will provide ten Quality
Engineers to support Quality Projects and Initiatives managed by the
Quality Department to meet their objectives in providing the highest
quality Risk Analysis and Hazard Reports on current active products.
Responsibilities:
- The SQA Associate will provide the following list of basic
quality engineering services:
- Identify and meet with primary contact to review the problem statement,
goal, scope, and milestones.
- Review current Work Instructions and SOP’s relating to Risk Management
- Procedure and Hazard Report Template.
- Convert Hazard reviews to new format, as defined by SOP and SOP Form.
- Deliverable: List of Hazard reviews ready for key stakeholder review.
- Determine Installed Base, Occurrence count of hazard and occurrence
of harm for each Hazard and calculate P1 and P2 rates.
- Deliverable: Completion of risk assessment for each individual Hazard.
- Meet with key expert personnel for the hazard report and evaluate the
document for accuracy and completeness as hazard reports are available.
- Deliverable: Hazard Report ready for team review.
General:
- Support Risk Assessment projects that require basic Engineering and
Project Management skills driven by process excellence thinking and
actions throughout the organization.
- Routinely work with cross functional personnel to define risk
assessments as pertains to the Hazard Reports.
Persons interested send cover letter and resume to Tim Lebetsamer
with subject "Job: SQA Services, Louisville, CO: Quality Engineers"
Via e-mail address Tim Lebetsamer
or to
550 Silver Spur Road, 3rd Floor
Rolling Hills, CA 90275
Phone (310) 802-4438
Fax (310) 544-5541
SQA Services web site
**** Bridgeport Hospital, CN: Performance Management Coordinator ***
Bridgeport Hospital (425 licensed beds) is a private, not-for-profit
hospital and a member of the Yale New Haven Health System.
It is the most comprehensive hospital in Fairfield County with 2,600
employees.
The Performance Management Coordinator reports directly to the VP
Performance Management and Risk, who is a MD.
Responsibility:
- The major responsibility of the Performance Management Coordinator is
to provide measurement, target definition, evaluation and reporting
expertise necessary to drive significant performance breakthroughs.
- The Coordinator will work with the Risk Management Department to identify
potential risk situations as well as with the Yale New Haven Health
System (YNHHS) Performance Management to achieve system wide
Performance Management initiatives.
- In addition, a significant portion of time is spent on issues
related to regulatory compliance.
Requirements
- The ideal candidate is detailed oriented, self-motivated and independent.
- At least 3 years' experience with analysis of administrative and clinical
health care data is required but may be attained through support
services.
Persons interested send cover letter and resume to
Email: Susan Carlow, Steve Harvey & Associates
**** University of Michigan Hospital, MI: Director of Program ***
The University of Michigan Hospitals and Health Centers is conducting a
search for a Director of Program & Operations Analysis
(Chief Industrial Officer), reporting to the Senior Associate Director
and Chief Operating Officer of the Hospitals and Health Centers.
Persons interested apply through the
University of Michigan Careers website: use Job ID: 39308.
This posting will be available until April 16, 2010.
Applications will not be taken via email or fax.
Mar 2010 - Jobs Postings
Middle: Mar e-mail:
*** Covidien, Carlsbad, CA: Senior Quality Engineer (09-0164) ****
Job Title: Respiratory Solutions - Senior Quality Engineer (09-0164)
Description
- Nellcor Puritan Bennett, is now the Respiratory and Monitoring Solutions
(RMS) business unit of Covidien, formerly Tyco Healthcare.
- RMS systems are used to monitor, diagnose and treat respiratory disease
and sleep disorders, and they provide life sustaining ventilation and
oxygen support for patients.
- In addition to Respiratory and Monitoring Solutions, Covidien also
manufactures, distributes and services a diverse range of industry-
leading product lines, including surgical devices, energy-based
devices, pharmaceutical products, imaging solutions, patient care and
safety products, and medical supplies.
- For more information, visit us at Coviden web site
SUMMARY OF POSITION:
- Integral member of the team representing quality engineering in design
and development of medical device products, primarily ventilators and
ventilation accessories, and facilitate the application of design
controls. Translate Quality Standards into processes and procedures,
and apply these to the new product design process.
ESSENTIAL FUNCTIONS:
- Assist R&D in the development of and/or review proposed new and modified
product designs for quality characteristics, including
manufacturability, serviceability, testability, reliability, and
conformance to product requirements.
- Ensure that product development projects and changes to existing products
are conducted in compliance with the FDA Quality System Regulation by
providing leadership to the team with respect to regulatory
requirements of new product development and/or product changes.
- Be highly engaged to ensure successful transfer of new products to
production facility. Review production processes for quality of
validation through IQ, OQ, and PQ activities.
- Assist in the development of design and process verification and
validation test plans. Ensure verification / validation results
demonstrate compliance to medical device standards.
- Represent Quality Engineering in the approval of protocols and reports,
ensuring defendable practices and conclusions.
- Provide training to project teams on verification/validation, statistical
methods and design controls.
- Accountable for product risk assessment efforts within product teams.
- Participate in and/or review all team deliverables for Design History
- Files and Technical Files for conformance to applicable requirements.
- Provide Quality support to facilitate the rapid resolution of product
complaints and/or safety issues.
- Conduct internal quality system and supplier quality audits.
Requirements
Minimum Requirements:
- 5-7 years of experience in a Quality Engineering role in the Medical
field. (MEDICAL INDUSTRY EXPERIENCE IS REQUIRED)
- Bachelor of Science degree in an engineering discipline, EE preferred
- 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
- Familiar with reliability analysis and test methods
- Familiar with ISO 14971, or strong experience in risk evaluation
techniques, such as FMEA and/or fault tree analysis
- CQE certification - desired
EEO/AA
Function: Quality
Division: Med Dev - Respiratory and Monitoring Products – HMRES
Persons interested send cover letter and resume to James Carter with
Subject: Respiratory Solutions - Senior Quality Engineer (09-0164)
Phone: +1 303-305-2608
email: James Carter
*** RT Logic, Colorado Springs, CO: Quality Assurance Lead ****
RT Logic is a leading supplier of ground signal processing systems (RF,
DSP, and digital domains) for satellite operations including factory test,
launch, bus operations, and assured mission capabilities. Our technology
also supports non-space applications. We have an exciting opportunity for
a full-time Quality Assurance Lead that has a wide range of experience
including software QA, hardware QA, and Printed Circuit Assemblies (PCA)
experience. Ideal candidate will be deeply knowledgeable on QA related
functions but bring flexibility to ensure balanced solutions for high-
technical, fast moving company.
This position will be responsible for:
- Leading the effort to integrate quality into our culture and everyday
work activities.
- Managing and tracking Corrective and Preventive actions with input from
the engineering staff and support programs through QA planning,
interaction with customers to address quality issues, supporting
customer on-site visits and customer surveys, and witnessing formal
testing.
- Performing all duties required of the ISO management representative for
both our Colorado Springs and Denver offices.
- This includes items such as developing, planning and conducting ISO
audits internally and for third parties, responding to external audit
non-conformances, conducting annual quality system review, developing
and tracking annual quality objectives and maintaining ISO related
process documents.
- Establishing and maintaining a software quality system that improves
software quality and customer satisfaction
- Performing inspections on hardware systems including verifying compliance
to drawings
- Performing final QA inspections on all delivered and returned equipment
- Planning, hardware QA Release inspections on all shipments and support
programs by witnessing formal testing when required.
- Interacting with customers to address quality issues, on-site visits and
surveys and present quality system overviews to customers.
- Ensuring compliance with ANSI/ESD S20.20-2007, perform annual inspections
on workstations and document, along with performing calibration on all
touch testers
- Documenting and following-up on Corrective and Preventive Actions taken
including reporting of verification actions.
- Providing quality metrics that show the health of the quality system
Leading a team that is focused on process improvement projects, including
tracking the status and documenting the results of PI actions
- Training personnel on company processes and brief the health and status
of the QA program as needed.
Requirements:
- BS or MS in Engineering or Computer Science, and 8+ years of related
experience is a must.
- In-Depth knowledge of the ISO standard required. ISO/IEC 12207:2008 and
CMMI Version 1.2 is a plus.
- Knowledge of standard coding lifecycles and practices
- In-depth knowledge of ISO 9001:2008 including planning and performing
internal audits, developing and tracking Quality Objectives, Quality
System review, developing and maintaining processes, and conducting
external audits.
- Experience with using ERP systems to collect data and track issues is
required. Previous experience with Epicor a plus.
- Knowledge of military, IEEE standards and ANSI/ESD S20.20. is required.
- Basic knowledge of how Printed Circuit Assemblies are designed including
Gerber files and schematics
- Knowledge of soldering techniques including surface mount soldering to be
used to evaluate and provide input to PCA contract manufacturers and
knowledge of hand soldering specifications such as J-STD-001 and
IPC-A-610.
- Basic understanding of software and hardware CM practices including the
use of CM tools including subversion.
RT Logic offers challenging work, an excellent environment, and great benefits!
U.S Citizenship and ability to obtain and secure a US Gov Security Clearance is
required. Please, no phone calls, agencies or recruiters.
Persons interested apply on-line at RT Logic web site
*** NREL, Golden, CO: EHS Specialist - Environmental Management System ****
Posting Title: EHS Specialist - Environmental Management System
Requisition Number: 1077BR
Location: Golden, CO
Position Type: Regular Employee
Hours Per Week; 40
Job/Research Summary
- Advanced level EHS position, having primary responsibility for the
development and implementation of NREL’s environmental management
system (EMS) and selected EHS programs and projects in support of EMS.
- Interacts with laboratory staff, administrative support staff, senior
managers, DOE, and regulatory agencies on a regular basis.
- Works with minimal direction providing guidance and subject matter
expertise in support of EMS-related activities, sustainability, and EHS
programs, projects, and tasks.
Job Duties
- Implement NREL’s Environmental Management System (EMS) and take an active
role in implementing sustainability program components as part of a
cross-organizational team.
- Establish EMS goals and executable strategies that will result in the
full implementation of the EMS at all levels of the organization.
- Coordinate activities necessary to achieve ISO 14001 certification.
- Develop, implement, and maintain assigned environmental programs to
address hazards existing at NREL and comply with regulatory
requirements.
- Programs may include such areas as NEPA, GRI reporting, environmental
permitting and compliance, air emissions, water programs, or
construction-related programs. As subject-matter expert, provide
interpretation and guidance to workers and other EHS Office staff for
assigned programs. Program assignments will involve advanced risk
assessment activities, conducting compliance reviews of regulations and
other requirements, and developing reports on technical work.
- Conduct and/or participate in pollution prevention assessments and
provide guidance to EHS and Laboratory staff regarding pollution
prevention opportunities.
- Identify environmental permitting and compliance requirements, and
develop and implement a process to meet those requirements.
- Provide support and back-up for environmental programs.
- Responsibilities include maintaining a working knowledge of NREL
environmental-related policies, programs, and procedures.
- May involve implementing requirements of any or all of NREL’s
environmental programs, such as environmental sampling, field
inspections of construction sites and laboratories, or working with
research and construction subcontractors.
- Conduct or assist in assessments, audits, and inspections of
environmental programs conducted by NREL, DOE, consultants or other
third parties, or external agencies. Develop and implement corrective
actions in response to the assessment findings.
- Develop and present training programs in support of EMS requirements and
assigned environmental programs. Training presentation methodologies
may include live, video, or electronic media. Provide back-up training
presentation support in environmental program areas assigned to others.
- Serve as a member of the NREL Emergency Response Team, for small to
moderate size releases of hazardous materials.
- Responsibilities include: participating in drills, classroom training,
wearing SCBA, spill response and clean-up, maintaining required
certifications, and other related activities.
Required Education and Experience
- Relevant Master's and 10 years experience or equivalent relevant
education/experience.
Additional Basic Required Knowledge, Skills and Abilities
- Demonstrated knowledge of environmental management systems, environmental
practices, and ability to develop and implement environmental program
and project activities.
- Advanced skills, abilities, and techniques in project management and
audit/assessments.
- ISO 14000 EMS Lead Auditor training.
- Advanced written and verbal communication skills and the ability to
interact with all levels of management and staff, DOE, external
agencies, and the public.
- Ability to simultaneously plan and manage multiple complex tasks.
- Demonstrated proficiency with basic computer software, e.g. Microsoft
Outlook, Word, Excel, PowerPoint, Project, etc.
- Occasional travel to project sites and meetings.
- Ability to perform occasional site work that can involve extreme weather
conditions, moderate physical exertion, and travel to geographically
remote sites.
- Ability to walk up to one mile continuously; able to stand continuously
for two hours; able to lift and carry forty-five pounds.
- Willingness and ability to participate in emergency response team
activities, including the ability to wear a full-face respirator and
Level B protection with Self-Contained Breathing Apparatus.
Preferred Qualifications
- Evidence of formal EMS training
- Experience with multiple Management Systems desired (e.g., ISO-9000,
ISO-14001, OHSAS 18000)
- ISO 14000 EMS Lead Auditor certification
- Ability to develop standards for Laboratory areas where little precedence
exists
- Advanced technical knowledge of EHS practices, procedures and techniques
- Experience working at a Department of Energy site.
- In-depth understanding of DOE and OSHA regulations.
- Demonstrated leadership abilities in programmatic planning,
organization, improvement and execution.
Persons interested apply on-line at NREL employment
via search job link with Requisition Number: 1077BR
*** NREL, Golden, CO: Research Technician - Metrology ****
Posting Title Research Technician - Metrology
Requisition Number 1139BR
Location: Golden, CO
Position Type: Regular Employee
Hours Per Week: 40
Job/Research Summary
- Entry-level technician position supporting the operations and development
of the NREL Metrology Laboratory by providing routine maintenance and
calibration of measurement and test equipment, and providing
administrative support in compliance with NREL’s Metrology Laboratory
policies and procedures.
Job Duties
- Performs routine maintenance and calibration of test instruments under
direct supervision of scientific and technical staff. Maintains a safe,
clean, and organized operating environment in accordance with NREL’s
safety policies and procedures.
- Assists senior technical staff with experimental set up, including
soldering, cabling, and wiring data acquisition instruments.
Contributes to the development and maintenance of the metrology
operations database.
- Perform general metrology laboratory administration, including equipment
purchases, calibration due notifications, receive/accept incoming
measuring and test equipment (MTE), inspect incoming MTE, schedule MTE
for repair and/or calibration, update calibration database, file MTE
calibration reports, and coordinate the return of MTE to owner.
- Work Schedule - Standard 40-hour workweek, Monday through Friday. Typical
work hours are 8:00 a.m. to 5:00 p.m. with some flexibility, occasional
overtime and weekend work is required.
Required Education and Experience
- Relevant Associates degree, or certification program or equivalent
relevant education/experience.
Additional Basic Required Knowledge, Skills and Abilities
- Demonstrated technical knowledge of metrology practices, calibration
procedure development, and test instruments (especially multifunction
calibrators, oscilloscopes, digital multi-meters and general-purpose
test instruments).
- Demonstrated exceptional interpersonal and communication (verbal and
written) skills. Effective computer skills for document generation,
basic data analysis tools, and basic data acquisition.
- Ability to interpret and develop electronic circuits.
- Exhibits attention to detail with high levels of innovation, initiative
and integrity.
- Must have (or be able to obtain) and maintain a valid Colorado driver’s
license with an acceptable driving record.
- Capable of routinely lifting 70 lbs.
A pre-hire physical screening will be required.
Preferred Qualifications
- Associate's degree in electrical engineering plus metrology training, or
Military training (Precision Measurement Equipment Laboratory-PMEL).
- One to three years of bench-level calibration experience, including
electrical/electronic instruments, temperature/humidity probes,
pressure transducers
Persons interested apply on-line at NREL employment
via search job link with Requisition Number: 1139BR
Feb 2010 - Jobs Postings
Middle: Mar e-mail:
*** SpeeCO, Golden, CO: Quality Engineer - 28566 ****
Denver area corporate headquarters has an opening for a QUALITY ENGINEER.
Position Summary
- The Quality Engineer will support the organization in maintaining the
organization’s quality program.
- Assures all internal and external customer requirements are met within
the framework of our mature ISO 9001:2008 Quality Management System.
- The ideal candidate will have a proven track record achieving successful
outcomes with strategic initiatives, complaint investigations, data
analysis, quality reporting and corrective/preventive action.
- In addition, the Quality Engineer will plan and direct quality activities
for inspection and/or testing of components, assemblies and
subassemblies.
- Plan and direct quality activities for incoming, in process, outgoing,
and new product development phases.
Experience and Skills:
- 3+ years experience in manufacture industry
- 3+ years experience in one or more related engineering areas such as
industrial, production, reliability, or design
- Comprehensive understanding of Quality Management Systems for receiving
inspection, control of nonconforming material, calibration, records
control, and document control applications
- Demonstrate ability to identify and evaluate complex quality or technical
issues and provide well thought out solutions
- Demonstrate ability to think critically; to be flexible and adaptable
while responding to the changing department demands as well as
anticipate and influence changes
- Demonstrate the ability to communicate effectively both orally and in
writing with all levels of management
- Demonstrate the ability to work effectively within the organization,
collaborate and provide inspection team with technical assistance
- Expertise in reading blueprints, engineering drawings and determine
appropriate tools/measuring instruments required to determine product
conformance
- Knowledge of manufacturing processes, specifications and inspection
criteria
- Skilled in advanced quality tools such as Failure Modes Effect Analysis
(FMEA), GD&T, SPC, Root Cause Analysis, and Poka-Yoke
- Skilled in computer applications including Microsoft Office and
statistical products
- Strong knowledge of drawing and schematic interpretation, and product
modeling
- Strong knowledge of statistical methods, data analysis, and reporting
Education Requirements
- ASQ Certification
- Associates Degree in Engineering; or related discipline;
or equivalent work experience
- Bachelor's Degree in Engineering or related discipline
Persons interested email cover letter and resume to HR at SpeeCO
With subject SpeeCO Job: Quality Engineer - 28566
For other SpeeCO Jobs see SpeeCO Careers Web page
*** SpeeCO, Golden, CO: Test Engineer ****
Denver area corporate headquarters has an opening for a TEST ENGINEER.
Position Summary
- The Test Engineer is responsible for the development, implementation and
reporting for validation testing requirements for the Company product
lines both domestically and abroad.
- Validation testing of Company products includes all new, released,
and existing products.
Experience and Skills:
- Ability to design new parts and assemblies using SolidWorks in the
creation of fixtures and test equipment;
- Ability to develop, operate, and maintain test equipment;
- Ability to document test results and report to organization;
- Ability to handle issues independently;
- Ability to perform basic manufacturing processes such as welding,
operating a lathe and mill;
- Ability to run development and validation tests on SpeeCo product lines;
- Ability to support inspection and re-work efforts of heavy mechanical
parts as necessary;
- Demonstrated ability to assist team members in solving business problems
and/or technical issues to effectively meet customer needs;
- Demonstrated ability to communicate effectively both orally and in
writing with all levels in organization and make formal presentations;
- Familiar to Designs of Experiments (DOE), FMEA's and statistical
analysis;
- Knowledge of agricultural industry;
- Knowledge of GD&T and first article inspection process;
- Knowledge of ISO quality management system is a plus.
- Knowledge of new product development procedures and processes;
- Perform validation of new suppliers to engineering test specifications;
- Proficient with MS Office Suite applications
- Strong knowledge of forging, casting, heat treat, materials selection,
machining, forming, welding, and finishes;
Education Requirements
- 4 year Technical Degree in Engineering;
- Bachelor of Science degree in Mechanical, Design or
- Industrial Engineering or related field.
Job Requirements
- 2+ years experience as a test engineer or related field.
Persons interested email cover letter and resume to HR at SpeeCO
With subject SpeeCO Job: Test Engineer
For other SpeeCO Jobs see SpeeCO Careers Web page
Jan 2010 - Jobs Postings
Middle Jan e-mail:
*** NREL, Golden, CO: Environmental Management System ****
Title: EHS Specialist - Environmental Management System
Requisition Number: 1077BR
Job Summary:
Advanced level EHS position, having primary responsibility for the
development and implementation of NREL's environmental management system
(EMS) and selected EHS programs and projects in support of EMS. Interacts
with laboratory staff, administrative support staff, senior managers,
DOE, and regulatory agencies on a regular basis. Works with minimal
direction providing guidance and subject matter expertise in support of
EMS-related activities, sustainability, and EHS programs, projects, and
tasks.
Job Duties:
- Implement NREL's Environmental Management System (EMS) and take an active
role in implementing sustainability program components as part of a
cross-organizational team. Establish EMS goals and executable
strategies that will result in the full implementation of the EMS at
all levels of the organization. Coordinate activities necessary to
achieve ISO 14001 certification.
- Develop, implement, and maintain assigned environmental programs to
address hazards existing at NREL and comply with regulatory
requirements. Programs may include such areas as NEPA, GRI reporting,
environmental permitting and compliance, air emissions, water programs,
or construction-related programs. As subject-matter expert, provide
interpretation and guidance to workers and other EHS Office staff for
assigned programs. Program assignments will involve advanced risk
assessment activities, conducting compliance reviews of regulations and
other requirements, and developing reports on technical work.
- Conduct and/or participate in pollution prevention assessments and
provide guidance to EHS and Laboratory staff regarding pollution
prevention opportunities.
- Identify environmental permitting and compliance requirements, and
develop and implement a process to meet those requirements.
- Provide support and back-up for environmental programs. Responsibilities
include maintaining a working knowledge of NREL environmental-related
policies, programs, and procedures. May involve implementing
requirements of any or all of NREL's environmental programs, such as
environmental sampling, field inspections of construction sites and
laboratories, or working with research and construction subcontractors.
- Conduct or assist in assessments, audits, and inspections of
environmental programs conducted by NREL, DOE, consultants or other
third parties, or external agencies. Develop and implement corrective
actions in response to the assessment findings.
- Develop and present training programs in support of EMS requirements and
assigned environmental programs. Training presentation methodologies
may include live, video, or electronic media. Provide back-up training
presentation support in environmental program areas assigned to others.
- Serve as a member of the NREL Emergency Response Team, for small to
moderate size releases of hazardous materials. Responsibilities
include: participating in drills, classroom training, wearing SCBA,
spill response and clean-up, maintaining required certifications, and
other related activities.
Required Education and Experience:
- Relevant Master's and 10 years experience or equivalent
relevant education/experience.
Additional Basic Required Knowledge, Skills and Abilities:
- Demonstrated knowledge of environmental management systems, environmental
practices, and ability to develop and implement environmental program
and project activities.
- Advanced skills, abilities, and techniques in project management and
audit/assessments.
- ISO 14000 EMS Lead Auditor training.
- Advanced written and verbal communication skills and the ability to
interact with all levels of management and staff, DOE, external
agencies, and the public.
- Ability to simultaneously plan and manage multiple complex tasks.
- Demonstrated proficiency with basic computer software, e.g. Microsoft
Outlook, Word, Excel, PowerPoint, Project, etc.
- Occasional travel to project sites and meetings. Ability to perform
occasional site work that can involve extreme weather conditions,
moderate physical exertion, and travel to geographically remote sites.
- Ability to walk up to one mile continuously; able to stand continuously
for two hours; able to lift and carry forty-five pounds. Willingness
and ability to participate in emergency response team activities,
including the ability to wear a full-face respirator and Level B
protection with Self-Contained Breathing Apparatus.
Preferred Qualifications
- Evidence of formal EMS training
- Experience with multiple Management Systems desired (e.g., ISO-9000,
ISO-14001, OHSAS 18000)
- ISO 14000 EMS Lead Auditor certification
- Ability to develop standards for Laboratory areas where little
precedence exists
- Advanced technical knowledge of EHS practices, procedures and techniques
- Experience working at a Department of Energy site. In-depth understanding
of DOE and OSHA regulations.
- Demonstrated leadership abilities in programmatic planning, organization,
improvement and execution.
Persons interested post your cover letter and resume via
web site: NREL Golden jobs
click on Search Openings link and search via Requisition Number: 1077BR
to find and apply for this job posting
*** LABS, Inc. Director of Regulatory Affairs & Quality Assurance ****
Seeking an experienced candidate to lead our Regulatory and Quality
department and direct future direction and growth. Ideal candidate will
have high level management experience; will be comfortable managing a
small team and equally comfortable working with the Executive Leadership
team.
Under administrative direction, assists company with the development,
implementation, management and continual improvement of an effective
quality assurance program. Serve as a regulatory resource to the
organization by providing input and opinions that are in compliance with
applicable rules and regulations. Manage and drive systems to closure
that are already established with the quality program. Serve as a role
model for company values and culture, consultant for internal/external
customers on compliance and regulatory issues.
Requirements:
- Experience working in a highly regulated industry (laboratory, devices,
pharmaceutical, or biology)
- Experience in a CAP, ASHI and/or AABB certified laboratory and/or in
a GMP or GLP environment
- Knowledge of laboratory services
- Knowledge and experience with regulatory/accreditation agencies
- Knowledge and experience in training and education
- Excellent written communication skills including writing, editing and proof reading.
- Excellent oral communication and facilitation skills.
Persons interested post your cover letter and resume in MS-Word format
to e-mail: Labs resumes
Early Jan e-mail:
*** Syncroness, Inc, Westminster, CO: Mid-Level QUALITY ENGINEER ****
Syncroness is looking for self-motivated and inquisitive mid-level quality
engineers for their Sustaining Engineering team, that enjoy variety and
challenges in the workplace. The chosen candidate for this position will
have:
- Bachelor's and/or Master's degree in Electrical Engineering
- Recent work history in the field of medical device development
- Familiarity with IEC60601-1 and ECG / Diagnostic ECG device standards
- Familiarity with FDA, Canadian and European device submissions
- Strong skills in technical writing and root-cause analysis
- Demonstrated knowledge of electronic component manufacturers
- Six to ten years industry experience (new graduates will not be
considered)
- ASQ certification as a Quality Engineer is a plus.
This engineer will be part of a 12-member team that provides ongoing
product support for seven different medical product lines, each related
to cardiac care and therapy. This team is responsible for:
- New feature additions
- Product bug fixes
- Customer problem resolution
- Software verification and validation
- Production releases of design updates
Primary responsibilities of this new team member will include:
- Developing working expertise on all supported products
- Resolving component availability issues
- Troubleshooting and debug of electrical issues
- Response to support requests from field reports
- New component validation planning, execution, and reporting
- Coordination of change notifications with safety agencies and
Notified Bodies
- Support of and/or leadership of product re-submissions
Syncroness hiring process is technical in nature and begins with a phone
screen, followed by a technical on-site interview.
Syncroness is not offering relocation compensation for this position.
Compensation will range from $50k to $70k depending on experience and
fit for the position.
Persons interested post your cover letter and resume in MS-Word format
With Position: Mid-Level QUALITY ENGINEER
to web page: Syncroness contact
Following the "Submit your resume" pop-up link
Dec 2009 - Jobs Postings
End Dec e-mail:
*** Boulder, CO: ISO 13485 Quality Engineer ***
Client is a leader in the development and production of technologies and
related techniques for aesthetic surgery. Their products reflect an
emphasis on science and quality. This thriving company was founded in
1998 and is proud to have ISO 13485 certification.
Essential Duties and Responsibilities
- Identify and document product specifications related to safety agency and
regulatory requirements
- Ensure safety and regulatory requirements (60601-1 and 60601-1-2) are
verified and validated
- Ensure that project activities are compliant with standard operating
procedures
- Maintain compliance with FDA Quality System Requirements (QSR) and
ISO 13485:2003 requirements
- Lead the development of product Risk Management per ISO 14971,
including development of Hazard Analysis and FMECA
- Ensure proper hazard mitigation
- Provide support on supplier corrective/preventive actions
- Supports and implements Quality Assurance system and program,
Including ISO/QSR documentation control
Education/Experience:
- Bachelor's degree in Electrical or Mechanical Engineering; or five to
ten years related experience and/or training; or equivalent
combination of education and experience.
Language Ability:
- Ability to read, analyze, and interpret common quality assurance
system documents, procedures and requirements
- Ability to write clear, concise and accurate reports of inspections and
supplier audits, as well as letters and other communications
with suppliers
- Ability to complete all required Quality Assurance forms and reports
clearly, completely and accurately
Math Ability:
- Ability to apply advanced mathematical concepts such as exponents,
logarithms, quadratic equations, and permutations.
- Ability to apply mathematical operations to such tasks as frequency
distribution, determination of test reliability and validity, analysis.
Technical Knowledge:
- Working knowledge of applicable UL and IEC 60601 regulatory requirements
related to medical devices, ISO/QSR design control requirements,
including verification and validation; working knowledge of
FDA QSRs, ISO 13485.
Compensation
- $70k- $75k base salary (some flex depending upon experience)
- Generous Health Insurance Policy
- Paid-Time off including sick and vacation days
- Much, much, more
Persons interested send cover letter and resume in MS-Word format to:
Jason W. Shirley Sr. Account Executive
E-mail: Jason Shirley
or phone call 303-447-9900 x115
*** Vestas Nacelles America, Brighton, CO: Quality Engineer ***
Title: Quality Engineer
Duration: 1 year job with Benefits & Bonus eligible!
Bonus: With successful employee performance and company ISO certification.
Vestas Nacelles America, Inc. will produce wind turbine nacelles in its
newest assembly factory in Brighton, Colorado, located just 20 miles
northeast of Denver. This facility is scheduled to open in March 2010 and
will be Vestas' 8th nacelles assembly factory worldwide.
The Quality Engineer will be responsible for:
- Assisting with implementation and certification of ISO 9000
- Interface with technical colleagues to document ISO 9000 procedures and processes.
- Communicate with Corporate Quality Department and train production
employees in ISO procedures and processes.
- Specific duties include the following:
- Heavy ISO documentation - new and revised - including flow diagrams
- Upload new/revised documents onto intranet portal
- Communicate with and train employees in production and various departments
- Auditing procedures
- Update documents as changes occur
- Control/maintain hardcopies
Qualifications:
- Requires advanced knowledge of ISO 9000
- Requires manufacturing work experience
- Requires experience training production employees
- Requires technical writing and document control
- Familiar with HTML
- PC skills: MS Word, Visio
- International travel required / passport
- Implementation of ISO program preferred
Persons interested send cover letter and resume including Job Title to:
Email: Brenda Leighton
Nov 2009 - Jobs Postings
Mid Nov e-mail:
*** Manpower Professional, Denver, CO: Quality Engineer ***
Job Title: Denver, CO: Quality Engineer
Key responsibilities:
- Develops and integrates a quality system and leads quality improvement
projects.
- Provides support and direction with regard to establishing effective
quality control measures while working in close collaboration with
Headquarters.
- Carries out quality control projects and ensures that quality
requirements are properly identified and defined and that improvement
measures are implemented and monitored to confirm effectiveness.
- Actively works to select the best suppliers and guides supplier quality
management in line with company control procedures.
- Continuously improves supplier quality by adopting improvement plans
with suppliers and carrying out supplier non-conformance management and
cause analysis.
- Develops, implements and maintains project quality plans for quality
control measures.
- Ensures that best practices are adopted within the supply chain to
guarantee highest levels of product integrity.
- Manages 8D reporting (complaint management) and employs measures that
allow for a continuous improvement process.
Qualifications and Requirements:
- Typically requires a master#s degree in Electrical or Mechanical
Engineering and a background in Quality Assurance or Quality
Engineering.
- At least 7 years of professional experience in Quality Management are
required as well as Technical Engineering expertise.
- Candidates with a bachelor's degree must have at least 10 years of
proven relevant professional experience in Quality Management and
Technical Engineering.
- Must have a profound understanding of Quality Management
(ISO 9001/TS 16949) and Key Quality Standards.
- Must have a proven background in Quality Assurance and a thorough
understanding of Quality Assessment tools and techniques: APQP
(Advanced Product Quality Planning), PPAP (Production Parts Approval
Process), Supplier and Process/Product Audit, Problem Solving/8D
Reporting and FMEA/Control Plan.
- Must possess excellent interpersonal, organizational, and written and
verbal communication skills and be persuasive while maintaining strong
business perspective and initiative.
- Has proven experience in a leadership role.
- Has experience with process improvement and other related techniques
and interacting with auditors and other 3rd parties.
- Must work with an attention to detail and a methodical approach.
- Working experience in an international company would be a plus.
- Must be willing to travel for audits, to oversee project negotiations
and to support suppliers.
Compensation and Benefits:
- Competitive salary.
- Excellent benefits package, including health insurance.
Persons interested send cover letter and resume including Job Title to:
Al Suarez, Manpower Professional, Inc.
Office: (303) 753-9599
Mobile: (303) 885-8744
e-mail: Al Suarez
*** Manpower Professional, Denver, CO: Final Inspection Production Manager ***
Job Title: Denver, CO: Final Inspection Production Manager
Final Inspection Production Manager
Key Responsibilities:
- Leads, coordinates and monitors the Final Inspection production area.
- Sets up and maintains the test equipment.
- Ensures optimal operations.
Cooperates closely with the Production Engineer regarding the use
of test systems.
- Conducts troubleshooting analysis.
Accountable for fault management in close cooperation with the
Headquarters' responsible product engineer.
- Responsible for recruiting and effectively organizing the Final
Inspection team members.
Qualifications and Requirements:
- Must have a bachelor's degree or other educational equivalent in
Electrical Engineering, Computer Engineering or other related area.
with proven experience in business administration.
- Has at least 7 years of professional experience in Power Electronics,
Electronic Manufacturing or related area. Ideally with a solid
understanding of electronic control cabinets and computer programming.
- Must be computer literate, ideally with experience using LabView, Linux,
SQL, Databases, Java, SAP, planning systems/approaches and measurement
tools.
- Must have proven experience in a leadership role.
- Is flexible and focused in a busy work environment.
- Has a results-oriented work ethic and inspires the same in others.
- Must possess excellent interpersonal, organizational, and written and
verbal communication skills.
Persons interested send cover letter and resume including Job Title to:
Al Suarez, Manpower Professional, Inc.
Office: (303) 753-9599
Mobile: (303) 885-8744
e-mail: Al Suarez
*** Manpower Professional, Denver, CO: Test Engineering and Repair Manager
***
Job Title: Denver, CO: Final Inspection Production Manager
Test Engineering and Repair Manager (Ref: 02005.1.9)
Key Responsibilities:
- Leads the Test Engineering and Repair team.
- Coordinates and monitors the Test Engineering and Repair area.
- In charge of testing procedures and supervising repairs.
- In charge of recruiting and effectively organizing the Test Engineering
and Repair team members.
- Ensures optimal operations.
- Cooperates closely with the Production Engineer regarding the use of
test systems.
Qualifications and Requirements:
- Must have a degree or professional training in the electronics field
with proven relevant professional experience in test engineering and
business administration.
- Must have proven experience in a leadership role.
- Is flexible and focused in a busy work environment.
- Has a results-oriented work ethic and inspires the same in others.
- Must possess excellent interpersonal, organizational, and written and
verbal communication skills.
Persons interested send cover letter and resume including Job Title to:
Al Suarez, Manpower Professional, Inc.
Office: (303) 753-9599
Mobile: (303) 885-8744
e-mail: Al Suarez
Oct 2009 - Jobs Postings
Mid Oct e-mail:
*** NREL, Golden, CO: Sr. QA Specialist I (Req ID 880BR) ***
Posting Title: Sr. QA Specialist I
Requisition Number: 880BR
Location: Golden, CO
Position Type: Regular Employee
Hours Per Week: 40
Job/Research Summary
This position provides advanced-level Quality Assurance services to the
Laboratory. Responsible for planning, directing, and implementing
specified QA Program projects in support of Laboratory and Office
priorities. Interact directly with senior management, line management,
and laboratory staff on a regular basis and work with minimal direction.
Play a key role in moving the Laboratory toward a mature Quality
Management System that is compliant with international standards such as
ISO 9001, ISO 17025, and ISO 14001.
Job Duties
- Support ongoing maintenance/implementation of NREL's QA Program
- Assist in developing QA work products including policies, lab-level
procedures, local desk procedures, and implementation tools
- Apply advanced QA technical and management skills to solve moderately
complex problems while implementing the QA Program across the
Laboratory
- Lead cross-cutting and focused QA assessments throughout the Laboratory
- Perform causal analysis, create formal assessment reports, and manage
corrective actions from assessments
- As a QA representative, provide advanced support and guidance to assigned
organizations.
- Support and guidance includes:
- Risk assessments
- Process development
- Measurement program development and data analysis
- Corrective action management
- Process improvement
- Assist Office management with annual QA Program/Project planning for the
QA Program
- Perform special project technical work: individually, as a team member,
or as a team lead
- Support ISO accreditation/certification efforts throughout the Laboratory
- Develop and conduct Quality-related training for NREL staff and educate
management about the QA Program. Training may also include
presentations at new employee orientation.
- Represent NREL in external forums, such as, EFCOG, Battelle Communities
of Practice and other DOE/national lab events. Make presentations at
forums, as requested.
Required Education and Experience'
- Relevant Master's Degree and 7 years experience or equivalent
relevant education/experience.
- Additional Basic Required Knowledge, Skills and Abilities
-- Additional Qualifications:
- Master's degree in a scientific or technical discipline is required;
or a combination of bachelor's degree, professional certification,
and relevant experience
- 10 years of relevant experience implementing Quality Management Systems
- Demonstrated advanced skills in one or more areas of the QA Program
and intermediate experience in project management or team/group
management
- Advanced QA skills, abilities, and techniques in select QA areas
- Ability to develop standards for Laboratory areas where little
precedence exists
- Evidence of formal Quality Assurance training is required (e.g.,
ISO Management Systems, Six-Sigma, Baldrige, CMMI, Conducting
Assessments, Process Mapping, Performing Root Cause Analysis,
Performance Measurements, etc.)
- Excellent interpersonal and communication skills
- Proficient at using all applications in the MS Office suite
Preferred Qualifications
- Experience with multiple Quality Management Systems desired
(e.g., ISO-9001, ISO-14001, OHSAS 18000, ISO-17025, ANSI-Z1.13,
DOE O 414.1, CMMI, etc.)
- Experience with implementing QA Programs within Research and
Development organizations
- Experience with developing QA work products for major and minor
construction projects. Work products include construction QA/QC Plans,
design verification checklists, and processes for performing
construction site walkthroughs and verification.
- Experience with the identification of suspect and counterfeit items
- Formal certification in the quality discipline desired (e.g., Certified
Manager of Quality/Organizational Excellence, Certified Quality
Auditor, Certified Quality Engineer, Certified Software Quality
Engineer, etc.)
Persons interested can get details and apply through NREL job posting page:
NREL employment jobs
Sep 2009 - Jobs Postings
Mid Oct e-mail:
*** Medtronic, Louisville, CO: Software Quality Engineer (Req ID 69062) ***
Division: Medtronic Surgical Navigation Technology
Position Description
- Works with minimal guidance to support the design, development, test, and
market release of software used in both surgical navigation applications
and other medical devices. Contribute to the processes and tools used to
create and test software applications. Develop and assess the quality
programs and systems of Medtronic Navigation to applicable standards.
Position Responsibilities
- Actively participate in product development cycle by reviewing software
project documentation, participating in product risk assessments, and
working closely with Product Development to develop appropriate
verification and validation testing requirements.
- Work cross-functionally to implement improvements to the software life
cycle, including the establishment of risk management as an integral part
of the quality management system as an overall framework for the
application of appropriate software engineering methods and techniques.
- Create and revise Standard Operating Procedures (SOPs) and other
documentation to support the Quality System in regards to software and
system design.
- Identify and implement software process metrics for the software product
development life cycle. Develop, analyze and monitor metrics pertaining
to software defects uncovered during development, testing and
post-release.
- Recommend and lead corrective and preventive actions to improve software
product quality. Ensure documentation and findings are completed on time
and in a timely manner in accordance with FDA and European Regulatory
agency standards and procedures.
- 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.
- Provide QA oversight to assigned suppliers. Disposition nonconforming
product at the Material Review Board meetings. Interface as necessary
with suppliers to ensure product specifications are met. Lead supplier
audits and assessments.
- Promote continuous improvement through the use of such tools as Lean,
Six Sigma and Kaizen.
- Follow all Quality System Practices as defined by Medtronic Navigation's
practices, policies and Standard Operating Procedures (SOPs) to ensure
that FDA, ISO and European Medical Device quality standards and
regulations are met where applicable.
Basic Qualifications
- B.S./B.A. in Engineering or similar related field
YEARS OF EXPERIENCE
- 5+ years of previous experience in an engineering position with B.S./B.A.
- 3+ years of previous experience in an engineering position with M.S./M.A.
- 0+ years of previous experience in an engineering position with Ph.D
Desired/Preferred Qualifications
- Working knowledge of FDA Quality System Regulations, Medical Device
Directive, ISO 13485, ISO 14971, and ISO 62304 standards.
- Skilled in product risk assessment, requirements management and tracing,
defect tracking, configuration management techniques, and how they are
applied in the software development lifecycle.
- Some knowledge in one or more of the following areas: C/C++, Linux/Unix,
Java, External Communication (RS-232, TCP/IP, wireless)
- Formal training in Lean and Six Sigma methods combined with project
deployment experience at the green belt or greater level is highly
desirable.
Physical Job Requirements
- 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 regularly
required to stand, sit, walk, talk, hear and reach with hands and arms.
The employee frequently is required to use hands to finger, handle, or
feel objects, tools, or controls. Specific vision abilities required by
this job include normal vision.
- WORK ENVIRONMENT: The work environment characteristics described here are
representative of those an employee encounters while performing the
essential functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet to moderate.
Persons interested please apply website at Medtronic general careers
Click on Career Opportunities -> US and Puerto Rico
Click yes for Security alert transfer dialog to
Medtronic specific US and Puerto Rico careers search
Search by Req ID: 69062
**** DONE with ASQ Section 1313 Job Postings *****
Section 1313 Web Page ASQ 1313 Section
Section 1313 E-mail Section Info