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Senior Quality Engineer - Plymouth, MN

 

Integer

 

 

At Integer, our vision and values are embedded in everything we do!

If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!

Accountabilities & Responsibilities:

  • Adheres to Integerís Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Identifies and evaluates procedures to ensure the production of quality product.
  • Develops new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
  • Applies engineering concepts to resolve acute or chronic problems.
  • Conducts studies to understand capability for process and/or measurement systems.
  • Provides management with technical guidance as required.
  • Identifies and develops appropriate documentation for process improvement and project implementation.
  • Maintains liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed.
  • Investigates and supports customer field experiences and supplier changes related to impacts of components, designs, and / or other process changes.
  • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
  • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
  • Provides management with technical guidance as required.
  • Identifies and procures the appropriate process equipment.
  • Investigates, develops and implements new process technologies of major scope.
  • Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
  • Subject matter expert in engineering specialty/application.
  • Performs other duties as required.

Job Requirements

Minimum Education: Bachelorís Degree in Engineering, Mathematics or Statistics required. Masterís Degree preferred.

Minimum Experience: 7+ yearsí experience in medical device or regulated manufacturing

Specialized Knowledge:

Competence in the selection and use of Quality Engineering Tools and Techniques.

Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, CFR, GxP, UL, MDD, TGA etc.)

Proficient in Microsoft Office and Minitab

Thorough knowledge and understanding of manufacturing quality requirements and solutions to obstacles that may impact successful transition at the component, subassembly, and final assembly levels

Special Skills:

Ability to work independently with minimal work direction and in a cross-functional team environment.

Ability to effectively communicate written and verbally.

Ability to manage time effectively to ensure timely completion of tasks.

Knowledge of SPC, FMEA, DOE, RCA, GDT

Sound knowledge of quality management systems.

Other:

Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.

 

 

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