Principal Quality Engineer

Integer

Not specified; not specified; not specified
Not specified
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 leadership in ensuring compliance with quality standards in medical device manufacturing. The ideal candidate will have over 10 years of experience, a strong background in engineering principles, and the ability to lead cross-functional teams

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while ensuring customer success.
  • You will lead regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
  • As a subject matter expert, you are expected to mentor engineers, supervise direct reports, and drive continuous improvement projects across the organization.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in ensuring compliance with quality standards in medical device manufacturing. The ideal candidate will have over 10 years of experience, a strong background in engineering principles, and the ability to lead cross-functional teams.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage CAPA and root cause analysis
  • Oversee product transfers and validation

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentorship and team supervision skills
  • Global customer interaction experience
  • Continuous improvement methodology adoption

Key Requirements

  • Bachelor's degree in engineering or related field
  • 10+ years of progressive engineering experience
  • Knowledge of FDA regulations and ISO standards

Work Rights

Not specified

Tailored Resume

Cover Letter