Principal Quality Engineer

Integer

Not specified
10+ years 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. The role requires extensive experience in engineering principles, quality management systems, and regulatory compliance in the medical device industry

Job Summary

  • This role provides strategic quality guidance to support Integer's goals in the medical device and battery manufacturing sectors.
  • The successful candidate will lead regulatory inspections, manage complaint investigations, and ensure adherence to FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will mentor engineers, drive continuous improvement projects, and interface with a global customer base.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization. The role requires extensive experience in engineering principles, quality management systems, and regulatory compliance in the medical device industry.

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage CAPA and non-conforming materials
  • 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 ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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