Principal Quality Engineer

Integer

Not specified (assumed to be onsite based on context)
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 the medical device industry. The role emphasizes innovation, collaboration, and adherence to quality management standards, with responsibilities including process improvement, compliance, and mentoring other engineers

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 complaint investigations, and ensure 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: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device industry. The role emphasizes innovation, collaboration, and adherence to quality management standards, with responsibilities including process improvement, compliance, and mentoring other engineers.

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 validation protocols

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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