Principal Quality Engineer

Integer

Not specified (potentially hybrid or onsite based on the role's nature).
10+ years progressive engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization, particularly in the realm of medical devices and specialized batteries. The ideal candidate will have a strong engineering background, at least ten years of experience, and a passion for quality and continuous improvement

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals as a subject matter expert.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • As a leader, you may supervise up to 4 to 5 engineering direct reports while serving as a coach and mentor for other engineers.

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 realm of medical devices and specialized batteries. The ideal candidate will have a strong engineering background, at least ten years of experience, and a passion for quality and continuous improvement.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • 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 mindset

Key Requirements

  • Bachelor's degree in engineering or related field
  • 10+ years of progressive engineering experience
  • Knowledge of FDA regulations and Quality Management Systems

Work Rights

Not specified

Tailored Resume

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