Principal Quality Engineer

Integer

10+ years progressive engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while ensuring customer success

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while ensuring customer success.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • As a subject matter expert, you are expected to mentor engineers, supervise up to five direct reports, and drive continuous improvement projects.

Matching Summary

The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while ensuring customer success.

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 method validation protocols

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentorship and team supervision skills
  • Continuous improvement methodology expertise
  • Global customer interaction capabilities

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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