Principal Quality Engineer

Integer

10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
  • The successful candidate will lead regulatory inspections, manage non-conforming materials, and ensure compliance with FDA regulations and Quality Management Systems.
  • You will supervise up to five engineering direct reports while collaborating with a global customer base to drive continuous improvement and innovation.

Matching Summary

This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.

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
  • Develop test method validation protocols
  • Supervise engineering direct reports

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience with global customer base
  • Mentorship and coaching capabilities

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations
  • QMS expertise
  • Leadership of inspection teams

Work Rights

Not specified

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