Principal Quality Engineer

Integer

Hybrid
10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in a dynamic environment focused on innovative medical technologies. The ideal candidate will have over 10 years of relevant experience and a strong technical background, particularly in quality management systems and regulatory compliance

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
  • The incumbent will lead regulatory agency inspections, manage product transfers, and ensure compliance with FDA regulations and Quality Management Systems.
  • Candidates must have 10+ years of experience and are expected to mentor up to 5 direct reports while driving continuous improvement initiatives.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in a dynamic environment focused on innovative medical technologies. The ideal candidate will have over 10 years of relevant experience and a strong technical background, particularly in quality management systems and regulatory compliance.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering field
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO, UL, MDD, TGA standards awareness
  • Mentorship and coaching capabilities
  • Global customer interaction skills
  • Continuous improvement mindset

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA and ISO regulations
  • Experience leading CAPA investigations

Work Rights

Not specified

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