Principal Quality Engineer

Integer

10+ years 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 applying intensive engineering knowledge

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive engineering knowledge.
  • You will lead regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
  • As a subject matter expert, you are expected to mentor other 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 applying intensive engineering knowledge.

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage CAPA and root cause analysis
  • Develop test methods and validation protocols

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and supervising engineering teams
  • 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 ISO standards

Work Rights

Not specified

Tailored Resume

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