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 and lead continuous improvement initiatives within the medical device manufacturing sector. The ideal candidate should possess over 10 years of engineering experience, strong technical aptitude, and leadership skills. **

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.
  • This role requires adherence to all safety, environmental, security, and quality requirements including FDA regulations and company policies.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and lead continuous improvement initiatives within the medical device manufacturing sector. The ideal candidate should possess over 10 years of engineering experience, strong technical aptitude, and leadership skills. **

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 methods and 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
  • Positive can-do attitude in high energy environment
  • Experience with global customer base interaction

Key Requirements

  • Bachelor's degree in engineering or related technical 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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