ASQ Boulder

American Society of Quality Professionals

Job Opportunities

Sr Software Design Quality Engineer at Covidien in Boulder CO

| Filed Under: Job Opportunities

General Information:

  • Company: Covidien, Boulder, CO
  • Location: Covidien, 5920 Longbow Dr, Boulder, CO 80301
  • Hiring: Sr Software Design Quality Engineer
  • Job ID Number: 140003KA

Overview Information

Via Covidien Job ID Number 140003KA web page

Job Description

  • Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients.
  • The Senior Software Design Quality Engineerensures that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.
  • Provide leadership, oversight and training to division manufacturing plants forsoftware design quality. Mentor design teams on quality systems and requirements.

What is the work you will be doing?

  • Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
  • Promote a structured software development process. Assure that control is maintained for in-house and outsourced software development.
  • Ensure compliance with internal and external procedures and regulations.
  • Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability and serviceability.

Required: experiences or skills

  • 5+ years of software design quality / compliance engineering experience or equivalent
  • Working knowledge of C++, the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle
  • Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products

Preferred: experiences or skills

  • Understanding of Object Oriented programming techniques
  • Working knowledge of Unified Model Language (UML)
  • ASQ CQE, CRE or CSQE certification
  • Strong familiarity with regulatory requirements (e.g. ISO 62304, ISO 13485, 21 CFR Part 11, 21 CFR 820, ISO 14971).
  • Experience in risk evaluation techniques, such as PRA (Product Risk Assessment), FMEA & fault tree analysis.
  • Familiar with reliability analysis and test methods, including HALT and HASS.

For more information and to apply contact Galit Dana, Lead Sourcing Specialist at Covidien

or visit Covidien Job ID Number: 140003KA web page

Plant Manager-Food, Beverage Industry in Baltimore, MD

| Filed Under: Job Opportunities

General Information:

Company: a Beverage Industry company

Hiring: Plant Manager-Food via The Kulwicki Group

Summary: Rapidly growing, multi-plant food processing company seeking an experienced Plant Manager for their plant in Maryland

Detail Information:

The Plant Manager’s role will:

  • Be responsible for overall plant operations for a state-of-the-art, non-union, 24/7 food processing facility
  • Develop, implement and maintain processes improvements to reduce costs
  • Develop plant budget and capital plans
  • Direct plant Safety programs to assure policy and procedure compliance

Background Profile:

  • Experience as a Plant Manager in a food / beverage processing plant
  • Bachelor’s degree
  • Lean Manufacturing / Continuous Improvement experience
  • Proven success at leading change and reducing costs

Company Offers:

  • Competitive base salary + bonus + strong benefits + relocation assistance

For more information and to apply contact

or ZipRecruiter job posted web page https://www.ziprecruiter.com/job/Plant-Manager-Food-Beverage-Industry/b8b5cdf6/

Director of Quality Assurance at Synergy Health AST in Denver CO

| Filed Under: Job Opportunities

General Information:

Company: Synergy Health AST, Denver, CO

Location: Synergy Health, 6750 East 46th Avenue Drive, Suite 100, Denver, CO 80216

Overview Information:

ESSENTIAL FUNCTIONS:

  • Establishes procedures for maintaining high standards of service, quality, reliability, and safety.
  • Determine and enforce – through functional groups – quality and regulatory requirements in accordance with company needs, based on current regulations and state-of-the-art product development.
  • Organize and promote companywide quality and service improvement efforts.

SUPERVISORY RESPONSIBILITIES:

  • Via matrix management, co-supervise the Quality Assurance Department of Synergy Health consisting of Service Facility Quality Assurance managers
  • Directly supervises the AST Corporate Quality Manager and Software Quality Engineer.

EXPERIENCE:

  • A minimum of 7 years of related experience with FDA registered companies is desired, with at least 2 years in quality management role.

KNOWLEDGE, SKILLS, ABILITIES:

  • Excellent verbal, written communication and mathematical skills required. Must be a team player.
  • Strong computer skills required, excellent working knowledge of MS Word, MS Excel.
  • Experience with Synergy Health’s current operating software preferred.
  • Ability to present and execute regulatory and quality programs working closely with senior management and facility personnel.

For more information and to apply see web page:  https://synergyhealthplc.applicantpro.com/jobs/138511.html

Sr Quality Engineer Failure Analysis at Medtronic in Louisville CO

| Filed Under: Job Opportunities

General Information:

 

Hiring: Sr Quality Engineer Failure Analysis (STQRA) – Job id 93489

Position Description

  • Provide failure investigation engineering support of Navigation systems throughout the product life cycle.
  • Participate in the product assurance of design, manufacturing, and testing of systems and components with an emphasis on electronic, mechanical, and electro-mechanical products.
  • Analyze field returns data for product and design improvement opportunity

For more information and to apply for see Job id 93489 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

Quality Systems Director at Medtronic in Louisville CO

| Filed Under: Job Opportunities

General Information:

 

Hiring: Quality Systems Director Navigation & Imaging (STQRA) – Job id 93590

Position Description

  • The Quality Systems Director is responsible for developing, implementing and driving the quality system for the Louisville, CO facility and providing Quality Systems leadership support to the Imaging facilities in Littleton, MA and Yokneam, Israel.
  • This role is responsible for developing common/harmonized QS procedures across 3 sites (where appropriate) as well as working across the Surgical Technologies sector to ensure common/harmonized QS procedures between the sector and the Louisville, Littleton, and Israel sites.
  • The Quality Systems Director will lead the quality system function to ensure quality system development and compliance with FDA’s Quality System Regulation, ISO 13485, MDD, MHLW and all other applicable requirements.
  • Additionally, this position will develop, establish and maintain effective quality system programs, architecture, content, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company standards necessary to maintain lasting consumer satisfaction.
  • This position requires strong leadership, communication, collaboration and relationship building cross-functionally within the three Navigation & Imaging sites and across the Surgical Technologies sector.

For more information and to apply for see Job id 93438 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

Sr Quality Engineer at Medtronic in Louisville CO

| Filed Under: Job Opportunities

General Information:

Hiring: Sr Quality Engineer(STQRA) – Job id 93438

Position Description

  • Assure the timely, accurate and independent evaluation of product performance and compliance to safety and regulatory requirements prior to market release of new products.
  • Support design changes and perform quality analysis of released products.
  • Collaborate with suppliers to ensure product specifications are met.
  • Recommend, plan and lead corrective and preventive actions for continuous improvement.
  • May specialize in areas such as design quality assurance, sustaining quality assurance, incoming quality assurance, production and inventory control, process validations, and/or supplier management.

For more information and to apply for see Job id 93438 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

Sr Software Quality Engr at Medtronic in Louisville CO

| Filed Under: Job Opportunities

General Information:

Hiring: Sr Software Quality Engr (STQRA) – Job id 92212

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.

For more information and to apply for see Job id 92212 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

 

 

Process Improvement Intern at CDOT, Denver, CO

| Filed Under: Job Opportunities

General Information:

Company: Colorado Dept of Transportation, Denver, CO

  • Hiring: Process Improvement Interns (Fall 2014 term)
  • CLASS TITLE: LTC Ops II
  • SALARY Range: $15.62/hr
  • LOCATION: 4201 E. Arkansas Ave. Denver, C0 80222
  • Applicagtion OPENING DATE: 6/12/14 to CLOSING DATE: 7/20/2014
  • This position is part-time to accommodate student schedules.
  • This is a paid temporary position with no benefits and will exist for 9 months or less.
  • Appointment may be made as early as July 1, 2014.

OVERVIEW OF JOB

The purpose of this collegiate internship is to provide meaningful professional process improvement experience to collegiate students with proven academic performance and a strong desire to learn and contribute.

The Office of Process Improvement provides the infrastructure, procedures, processes, training, and support which facilitate and promote a culture of continuous improvement at CDOT.

DUTIES include the following but not limited to:

  • Assisting CDOT process improvement projects with:
    • Characterizing and documenting basic process and operating information;
    • Assessing the effectiveness and efficiency of processes (including the use of continuous improvement methodologies);
    • Developing recommendations for improving operations;
  • Providing a summary presentation at the conclusion of the internship regarding the internship experience;
  • Assist instructors who provide training in process improvement methods, tools, and techniques; and
  • Perform other duties as assigned.

This position is located on CDOT’s Headquarters Campus, 4201 E. Arkansas Avenue in Denver, Colorado.

Additional information about the process improvement internship experience is available at:

http://www.coloradodot.info/business/process-improvement/internship-opportunities-in-process-improvement

Education and Experience Requirements:

  • Qualified candidates must be enrolled as an undergraduate or graduate student at an accredited college or university, college, or similar learning institution, with at least a 3.0 cumulative GPA during the last completed semester/quarter.
  • Please note: if you were enrolled during the Spring term of 2014, and will continue enrollment during Fall term of 2014, you may apply on this position.
  • A copy of your transcripts must be attached to this application.
  • The Exceptional Candidate will be an undergraduate college/university student interested in applying process improvement techniques in an organization and has proven accomplishments in the following:
  • Completion of 3 years or more in an accredited university in a process improvement curriculum or a discipline related to process improvement (such as industrial engineering, systems engineering, quality assurance, business management, operations research, or management science).
  • Knowledge and experience with continuous improvement technologies such as Total Quality Management (TQM), Theory of Constraints, Operational Excellence, Lean Enterprise, or Six Sigma.
  • Knowledge and experience with documenting processes and operations.
  • Knowledge of change management (the people side of change).
  • Excellent interpersonal skills
  • Excellent verbal and written communication skills.
  • Ability to perform duties with minimal supervision.
  • Familiarity with the Microsoft Office suite (including Visio), and Microsoft Outlook; experience with Microsoft SharePoint knowledge a plus.

To Apply on-line:

Go to www.colorado.gov/cojobs and view the announcement under Department of Transportation.

Application Checklist – A completed application must include:

  • Attach a cover letter explaining your qualifications and interest in this position.
  • Attach a current copy of your college / university transcripts in the “Attachment ” section of this application.
  • Attach a chronological resume to the “Attachment” section of this application.

For more information contact:

Quality Associate, Sartorius, Arvada, CO

| Filed Under: Job Opportunities

 General Information:

Sartorius  is looking for Quality Associate in Arvada CO

Reports to: Quality Manager

Position Summary:

  • At the Arvada site, administer and oversee the requirements defined by the North America quality management system to ensure that products manufactured at the site consistently meet performance and quality specifications.
  • Additionally ensure that all processes related to the distribution of products meet local and global policy requirements.
  • Assist as needed to ensure that the North American quality management system is properly managed and maintained.

Essential Duties and Responsibilities:

  • Ensure that the Arvada site complies with established quality requirements for ISO 9001 and GMP’s for the controlled distribution of products including medical devices
  • Perform incoming inspection of all raw materials and components used for manufacturing
  • Release finished products for distribution
  • Perform any required CAPA or Deviation investigations
  • Assist Process Engineer with the investigation of any customer, vendor, and internal quality issues or complaints
  • Create, review and sign off any related documents or records
  • Ensure applicable equipment used in manufacturing is properly calibrated, and preventive maintenance schedules and activities are maintained
  • Perform quality check of all products received for distribution and required inspections of all returned products
  • Ensure that returned products requiring complaint investigation are dispatched to the proper quality group
  • Ensure that any quarantined products are controlled properly and cannot be used in manufacturing or placed into distribution
  • Perform internal audits for compliance to the quality management system
  • Assist site management team as needed to meet site quality goals and objectives
  • Assist North American Corporate Quality with the collection of data for the management review
  • Perform vendor quality system audits for North American vendors
  • Perform site registration with FDA for importer distributor of medical devices
  • Keep track of all data related to the handling or distribution of medical devices in North America
  • Assist Corporate Quality in New York as needed regarding North American quality issues
  • Assist in hosting third party audits in Arvada

Qualifications and Requirements:

  • BS in any Quality/Engineering/Science discipline with 3-5 years’ experience, or AS in any Quality/Engineering/Science discipline with 5-7 years’ experience
  • Knowledge of manufacturing and distribution
  • Knowledge of ISO-9001, and current FDA Good Manufacturing Practices
  • Understanding of quality systems methods
  • Experience in internal auditing and vendor auditing
  • Problem-solving and analytical skills
  • Good verbal and written communication skills
  • Ability to work independently and in a team environment
  • Able to interact with all levels inside and outside the organization
  • Some physical work required – must be able to lift 50-lbs
  • Strong Microsoft Office skills
  • Traveling is expected, ~15%

Additional Comments:

  • All qualified applicants will receive consideration for employment without regard to race, creed, color, or national origin.

If you are interested in this opportunity, please apply online at http://www.sartorius.us/us/company/careers/vacancies/job/show/8349

Contract QC inspectors and auditors, PRO QC, Boulder-Denver CO area

| Filed Under: Job Opportunities

General Information:

Pro QC International is looking for contract QC inspectors and/or auditors in the Boulder-Denver Colorado Metro Area

  • Pro QC is an international third party quality consulting and engineering firm.
  • Our services include but are not limited to quality inspections, product testing, corrective action, and supplier audits (TS16949, SA8000, ISO9001, QS9000, etc).
  • Learn more about us at  http://www.proqcna.com/

Job Information

  • Pro QC is currently seeking contracted quality assurance inspectors and auditors to assist with projects across the USA, Canada and Mexico.
  • Pro QC has Boulder CO and Denver CO offices
  • Inspections generally include quantity verification and random sampling for visual/workmanship evaluation, functional testing, and packaging integrity verification.
  • Sampling employed follows ANSI Z1.4 specifications (MIL105E).
  • Interested candidates should be comfortable providing electronic reports and should have a digital camera.
  • Reports are in a MS Word format.

Additional Information:

  • Contract Projects Only (1099)
  • BS in Mechanical or Industrial Engineering or CQE/CQI preferred.
  • ASQ, ISO, RABQSA or credentials from similar body along with industry experience are also preferred.
  • Additional Salary Information: 1099 Hourly + IRS Mileage

More information and to apply with Resume and cover letter