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 guidance in quality management, ensuring compliance with regulations and customer expectations while fostering a culture of innovation and collaboration. The role requires extensive engineering expertise and leadership skills to drive continuous improvement and maintain high-quality standards in the medical device and specialized battery manufacturing sectors

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 leader, you may provide supervision for up to 4 to 5 engineering direct reports while serving as a coach and mentor.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic guidance in quality management, ensuring compliance with regulations and customer expectations while fostering a culture of innovation and collaboration. The role requires extensive engineering expertise and leadership skills to drive continuous improvement and maintain high-quality standards in the medical device and specialized battery manufacturing sectors.

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

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO, UL, MDD, TGA standards awareness
  • Strong written and oral communication skills
  • Experience with global customer base
  • Ability to mentor and supervise engineers
  • Positive can-do attitude in high energy

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations
  • QMS and ISO standards expertise
  • Supervisory experience for 4-5 reports

Work Rights

Not specified

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