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 leadership in the medical device sector. The ideal candidate will have over 10 years of engineering experience and a strong background in quality management systems, regulations, and continuous improvement processes. **

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals as a subject matter expert.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • As a recognized authority, you are expected to supervise up to 4 to 5 engineering direct reports while serving as a coach and mentor.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device sector. The ideal candidate will have over 10 years of engineering experience and a strong background in quality management systems, regulations, and continuous improvement processes. **

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 skills
  • Experience with global customer base
  • Positive can-do attitude under pressure
  • Mentorship and coaching capabilities

Key Requirements

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

Work Rights

Not specified

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