Principal Quality Engineer

Integer

10+ years engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
This role provides strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors

Job Summary

  • This role provides strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.
  • The successful candidate will lead regulatory inspections, manage non-conforming materials, and ensure adherence to FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will mentor engineers, supervise up to five direct reports, and drive continuous improvement projects across global operations.

Matching Summary

This role provides strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes
  • Develop test method validations

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentorship and team supervision skills
  • Global customer interaction experience
  • Continuous improvement methodology adoption

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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