Principal Quality Engineer

Integer

**
10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device manufacturing sector. The ideal candidate will have over ten years of progressive engineering experience, strong technical aptitude, and a commitment to quality, compliance, and continuous improvement. **

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 be responsible for developing new approaches to complex problems, leading continuous improvement projects, and mentoring up to five direct reports.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device manufacturing sector. The ideal candidate will have over ten years of progressive engineering experience, strong technical aptitude, and a commitment to quality, compliance, and continuous improvement. **

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

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and coaching engineering teams
  • Global customer interaction experience
  • Continuous improvement methodology expertise
  • Strong written and oral communication skills

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA and ISO regulations
  • Experience with medical device manufacturing
  • Ability to work independently and collaboratively

Work Rights

Not specified

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