Principal Quality Engineer

Integer

Not specified
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, ensuring compliance with quality standards in medical device manufacturing. The ideal candidate will possess over 10 years of engineering experience and demonstrate strong leadership, problem-solving, and communication skills

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive quality knowledge principles.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • As a subject matter expert, you are expected to mentor up to 4 to 5 engineering direct reports and collaborate with a global customer base.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance, ensuring compliance with quality standards in medical device manufacturing. The ideal candidate will possess over 10 years of engineering experience and demonstrate strong leadership, problem-solving, and communication skills.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering field
  • FDA regulations and QMS knowledge
  • ISO and international standards awareness
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes
  • Develop test methods and validation protocols

Nice-to-have

  • Master's degree or Doctorate preferred
  • Experience with global customer base
  • Mentorship and coaching capabilities
  • Continuous improvement project leadership
  • Strong written and oral communication
  • Ability to work independently
  • Positive can-do attitude

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations
  • Familiarity with ISO and QSR standards
  • Supervisory experience for 4-5 engineers

Work Rights

Not specified

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