Principal Quality Engineer

Integer

**
10+ years progressive engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
** Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance and leadership to ensure compliance with quality management systems in the medical device manufacturing sector. The ideal candidate will have over 10 years of engineering experience, a strong technical background, and a commitment to the company's core values of customer focus, innovation, and collaboration. **

Job Summary

  • This role serves as a strategic authority providing quality guidance to support the company's goals in the medical device industry.
  • The incumbent will lead regulatory agency inspections, manage complaint investigations, and ensure adherence to FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will mentor up to five direct reports while driving continuous improvement projects and product transfers.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance and leadership to ensure compliance with quality management systems in the medical device manufacturing sector. The ideal candidate will have over 10 years of engineering experience, a strong technical background, and a commitment to the company's core values of customer focus, innovation, and collaboration. **

Skills & Requirements

Must-have

  • 10+ years progressive 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 engineering teams
  • Global customer interaction skills
  • Continuous improvement methodology adoption

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter