Principal Quality Engineer

Integer

Not specified (potentially hybrid or onsite based on role requirements).
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 within the company. The role requires extensive knowledge of engineering principles and a focus on ensuring product quality for medical devices, along with fostering collaboration and innovation

Job Summary

  • This role provides strategic quality guidance to support Integer's goals in the medical device and energy markets.
  • The successful candidate will lead regulatory inspections, manage non-conforming material processes, and ensure compliance with FDA regulations.
  • You are expected to mentor up to five direct reports while collaborating with a global customer base to drive innovation.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the company. The role requires extensive knowledge of engineering principles and a focus on ensuring product quality for medical devices, along with fostering collaboration and innovation.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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