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 supporting the company's goals, particularly in the medical device manufacturing sector. The ideal candidate will have extensive engineering experience, familiarity with quality management systems, and the ability to lead continuous improvement projects. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
  • The successful candidate will lead regulatory inspections, manage non-conforming materials, and ensure compliance with FDA regulations and Quality Management Systems.
  • You will supervise up to five engineering direct reports while collaborating with a global customer base to drive continuous improvement and innovation.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in supporting the company's goals, particularly in the medical device manufacturing sector. The ideal candidate will have extensive engineering experience, familiarity with quality management systems, and the ability to lead continuous improvement projects. **

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
  • Positive can-do attitude
  • Experience with global customer base
  • Continuous improvement ideation skills
  • Calm demeanor in high energy environment

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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