Principal Quality Engineer

Integer

Not specified in the job description.
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 within the organization, particularly in the medical device manufacturing sector. The ideal candidate will have extensive experience in engineering roles and a strong focus on quality management systems, with a commitment to the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity

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 product transfers, and ensure compliance with FDA regulations and Quality Management Systems.
  • You are expected to mentor up to five direct reports while collaborating with global customers to drive continuous improvement and innovation.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization, particularly in the medical device manufacturing sector. The ideal candidate will have extensive experience in engineering roles and a strong focus on quality management systems, with a commitment to the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity.

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

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication
  • Mentorship and coaching capabilities
  • Global customer interaction experience

Key Requirements

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

Work Rights

Not specified

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