Principal Quality Engineer

Integer

**
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 in the medical device manufacturing sector. The ideal candidate will have extensive experience in engineering roles, emphasizing quality management and compliance with regulations. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals while ensuring internal and external customer expectations are met.
  • The successful candidate will lead regulatory and agency inspections, manage complaint investigations, and ensure adherence to FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will supervise up to five direct reports, mentor other engineers, 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 in the medical device manufacturing sector. The ideal candidate will have extensive experience in engineering roles, emphasizing quality management and compliance with regulations. **

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes
  • Develop test method validation protocols

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication skills
  • Experience with global customer base
  • Ability to mentor and supervise engineers

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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