Principal Quality Engineer

385

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10+ years engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in manufacturing and engineering processes, particularly for medical devices. The ideal candidate will have over 10 years of experience in quality engineering and a strong educational background in engineering, along with knowledge of industry regulations. **

Job Summary

  • This role provides strategic quality guidance to support the company's goals in the medical device and energy markets.
  • The successful candidate will lead regulatory inspections, manage non-conforming material processes, and ensure compliance with FDA regulations.
  • You will serve as a subject matter expert, mentoring engineers and driving continuous improvement projects across global operations.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in manufacturing and engineering processes, particularly for medical devices. The ideal candidate will have over 10 years of experience in quality engineering and a strong educational background in engineering, along with knowledge of industry regulations. **

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Process validation and capability studies
  • Root cause analysis and CAPA management

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and supervising engineering teams
  • Global customer interaction skills
  • Continuous improvement mindset

Key Requirements

  • Bachelor's degree in engineering required
  • 10+ years of progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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