Principal Quality Engineer

Integer

**
10+ years progressive engineering experience
Bachelor's degree in engineering or related field
Fda regulations and qms knowledge
** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance within a global medical device organization. The ideal candidate should have over 10 years of experience in engineering roles, a strong technical aptitude, and a commitment to quality and collaboration. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a global organization serving Medical Device OEMs.
  • The incumbent will lead regulatory and agency inspections while ensuring compliance with FDA regulations and Quality Management Systems.
  • Candidates must demonstrate subject matter expertise with 10+ years of experience to solve complex problems impacting the business.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance within a global medical device organization. The ideal candidate should have over 10 years of experience in engineering roles, a strong technical aptitude, and a commitment to quality and collaboration. **

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering or related field
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes
  • Develop test methods and validation protocols

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO, UL, MDD, TGA standards awareness
  • Mentorship and coaching capabilities
  • Global customer interaction skills
  • Continuous improvement ideation
  • 5 Sigma journey participation

Key Requirements

  • 10+ years of progressive engineering experience
  • Bachelor's degree in engineering required
  • Knowledge of FDA regulations and QMS
  • Experience leading regulatory inspections
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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