Principal Quality Engineer

Integer

10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
This role serves as a strategic authority providing quality guidance to support Integer's goals in the medical device and battery manufacturing sectors

Job Summary

  • This role serves as a strategic authority providing quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.
  • The incumbent will lead regulatory inspections, manage non-conforming material processes, and drive continuous improvement projects to ensure product integrity.
  • As a subject matter expert, you will mentor up to five direct reports while collaborating with a global customer base to establish and maintain strong relationships.

Matching Summary

This role serves as a strategic authority providing quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering field
  • FDA regulations and QMS knowledge
  • ISO and international standards awareness
  • Root cause analysis and CAPA leadership
  • Process validation and test method development
  • Bill of Materials and design review

Nice-to-have

  • Master's degree or Doctorate preferred
  • Strong written and oral communication skills
  • Ability to work independently and collaboratively
  • Positive can-do attitude in high-energy environment
  • Experience leading global customer interactions
  • Mentorship and coaching capabilities

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA and ISO regulations
  • Experience with Medical Device OEMs

Work Rights

Not specified

Tailored Resume

Cover Letter