Principal Quality Engineer

karrierexxl.de

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10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
** Integer seeks a Principal Quality Engineer to provide strategic quality guidance, ensuring compliance with regulations and internal standards while fostering innovation and collaboration. The ideal candidate will possess extensive engineering experience and a strong commitment to quality management in the medical device and specialized battery sectors. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals while ensuring internal and external customer expectations are met or exceeded.
  • The successful candidate will lead regulatory and agency inspections, manage non-conforming material processes, and drive continuous improvement projects within a global medical device organization.
  • As a subject matter expert, you will supervise up to five direct reports, mentor engineers, and ensure adherence to strict FDA regulations and Quality Management Systems.

Matching Summary

Match Score: 75

** Integer seeks a Principal Quality Engineer to provide strategic quality guidance, ensuring compliance with regulations and internal standards while fostering innovation and collaboration. The ideal candidate will possess extensive engineering experience and a strong commitment to quality management in the medical device and specialized battery sectors. **

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering field
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Root cause analysis and CAPA management

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO, UL, MDD, TGA standards awareness
  • Mentoring and coaching engineering teams
  • Global customer interaction skills
  • Continuous improvement mindset

Work Rights

Not specified

Tailored Resume

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