Principal Quality Engineer

Integer

Not specified; not specified; not specified
Hybrid
10+ years progressive 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, ensuring compliance with industry standards and enhancing product quality for medical devices and specialized batteries. The ideal candidate will possess over 10 years of engineering experience, a strong technical background, and a commitment to the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity

Job Summary

  • The role involves providing strategic quality guidance to support Integer's goals in the medical device and energy battery sectors.
  • You will lead regulatory and agency inspections while ensuring compliance with FDA regulations and Quality Management Systems.
  • As a subject matter expert, you are expected to mentor up to five direct reports and drive continuous improvement projects.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership, ensuring compliance with industry standards and enhancing product quality for medical devices and specialized batteries. The ideal candidate will possess over 10 years of engineering experience, a strong technical background, and a commitment to the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage CAPA and root cause analysis
  • Review BOMs and control plans

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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