Principal Quality Engineer

486

Not specified
10+ years engineering experience
Fda regulations and qms knowledge
Process validation and capability studies
Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance to ensure compliance with industry standards while enhancing product quality for medical devices and niche batteries. The ideal candidate will have significant engineering experience, demonstrate leadership in quality management, and align with the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity

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 non-conforming material processes, and ensure adherence to FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will mentor engineers, lead continuous improvement projects, and interface with a global customer base.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance to ensure compliance with industry standards while enhancing product quality for medical devices and niche batteries. The ideal candidate will have significant engineering experience, demonstrate leadership in quality management, and align with the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity.

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Process validation and capability studies
  • Root cause analysis and CAPA management
  • Bill of Materials review expertise
  • Regulatory inspection leadership

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and coaching skills
  • Continuous improvement ideation
  • Global customer interaction experience

Key Requirements

  • Bachelor's degree in engineering or related field
  • 10+ years of progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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