Principal Quality Engineer

128

Not specified
10+ years engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance and leadership within the organization. The role requires extensive experience in engineering principles, with a strong focus on quality management in the medical device industry. ###

Job Summary

  • This role provides strategic quality guidance to support the company's goals in the medical device and energy markets.
  • The successful candidate will lead regulatory inspections, manage non-conforming material processes, and drive continuous improvement projects.
  • As a subject matter expert, you will mentor engineers, supervise direct reports, and ensure adherence to FDA regulations and Quality Management Systems.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance and leadership within the organization. The role requires extensive experience in engineering principles, with a strong focus on quality management in the medical device industry. ###

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Root cause analysis and CAPA management
  • Process validation and capability studies

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and supervising engineering teams
  • Global customer interaction experience
  • Continuous improvement methodology expertise

Key Requirements

  • Bachelor's degree in engineering required
  • 10+ years of progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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