Principal Quality Engineer

Integer

Not specified (assumed to be hybrid given the nature of the role).
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 ensure compliance with industry standards for medical devices and specialized applications. The ideal candidate will possess extensive engineering experience and a strong technical aptitude, with a focus on continuous improvement and collaboration

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 agency inspections, manage complaint investigations, and ensure compliance with FDA regulations and Quality Management Systems.
  • You will supervise up to five engineering direct reports while collaborating with a global customer base to drive continuous improvement and market innovation.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and ensure compliance with industry standards for medical devices and specialized applications. The ideal candidate will possess extensive engineering experience and a strong technical aptitude, with a focus on continuous improvement and collaboration.

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
  • Supervise up to 5 direct reports

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience with global customer base
  • Mentoring and coaching capabilities

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations
  • QMS expertise
  • Leadership of 4-5 engineers

Work Rights

Not specified

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