Principal Quality Engineer

Integer

Not specified
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 lead quality initiatives and provide strategic guidance in a collaborative, innovative culture focused on enhancing medical device technologies. The ideal candidate will have over 10 years of experience in engineering roles, with a strong emphasis on quality management systems and regulatory compliance

Job Summary

  • This role serves as a subject matter expert providing strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.
  • The incumbent will lead regulatory and agency inspections, manage complaint investigations, and ensure adherence to FDA regulations and Quality Management Systems.
  • Candidates are expected to possess over 10 years of progressive engineering experience and demonstrate the ability to work independently while mentoring up to five direct reports.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to lead quality initiatives and provide strategic guidance in a collaborative, innovative culture focused on enhancing medical device technologies. The ideal candidate will have over 10 years of experience in engineering roles, with a strong emphasis on quality management systems and regulatory compliance.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering or related field
  • FDA regulations and QMS knowledge
  • ISO and international regulatory standards
  • 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
  • Experience with 5 Sigma initiatives
  • Strong written and oral communication skills
  • Ability to mentor and supervise engineers
  • Positive can-do attitude in high energy environment
  • Global customer base interaction experience
  • Process capability study expertise

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations and ISO standards
  • Experience leading CAPA activities
  • Supervisory experience for 4-5 engineers

Work Rights

Not specified

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