Principal Quality Engineer

Integer

**
10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and ensure compliance with quality standards in the medical device and specialized battery manufacturing fields. The ideal candidate will have extensive engineering experience, strong leadership skills, and a commitment to innovation and collaboration within a culture that values integrity and inclusion. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals while serving as a subject matter expert in medical device manufacturing.
  • The incumbent will lead regulatory inspections, manage complaint investigations, and ensure compliance with FDA regulations and Quality Management Systems.
  • As a recognized authority, you will supervise up to five engineers, mentor the team, and drive continuous improvement projects across the organization.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and ensure compliance with quality standards in the medical device and specialized battery manufacturing fields. The ideal candidate will have extensive engineering experience, strong leadership skills, and a commitment to innovation and collaboration within a culture that values integrity and inclusion. **

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
  • Manage non-conforming material processes
  • Develop test method validation protocols
  • Supervise engineering direct reports

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience with global customer base
  • Mentoring and coaching capabilities
  • Calm demeanor in high energy environment

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations
  • QMS expertise required
  • Leadership of inspection teams

Work Rights

Not specified

Tailored Resume

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