Principal Quality Engineer

Integer

10+ years engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
This role provides strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors

Job Summary

  • This role provides strategic 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 ensure compliance with FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will mentor engineers, lead continuous improvement projects, and drive product transfers while maintaining a focus on safety and innovation.

Matching Summary

Match Score: 85

This role provides strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Process capability studies and validation
  • Root cause analysis and CAPA management

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and supervising engineering teams
  • Global customer interaction experience
  • Continuous improvement methodology expertise

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

Cover Letter