Principal Quality Engineer

331

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10+ years engineering experience
Fda regulations and qms knowledge
Process validation and capability studies
** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance supporting their medical device and specialized battery manufacturing. The ideal candidate should have extensive engineering experience, leadership skills, and a commitment to quality, aligned with Integer's core values. **

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, audits, and investigations while ensuring compliance with 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

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance supporting their medical device and specialized battery manufacturing. The ideal candidate should have extensive engineering experience, leadership skills, and a commitment to quality, aligned with Integer's core values. **

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Process validation and capability studies
  • Root cause analysis and CAPA management
  • Bill of Materials and FMEA review

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and supervising engineers
  • Global customer interaction skills
  • Continuous improvement methodology adoption

Key Requirements

  • Bachelor's degree in engineering or related field
  • 10+ years of progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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