Principal Quality Engineer

Integer

10+ years engineering experience
Fda regulations and qms knowledge
Iso and international standards awareness
This role provides strategic quality guidance to support the company's goals in the medical device and battery manufacturing sectors

Job Summary

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

Matching Summary

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

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • ISO and international standards awareness
  • Root cause analysis and CAPA management
  • Process validation and capability studies

Nice-to-have

  • Master's degree or Doctorate preferred
  • Strong written and oral communication
  • Mentoring and supervising engineers
  • Global customer interaction experience
  • 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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