Principal Quality Engineer

163

**
10+ years engineering experience
Fda regulations and qms knowledge
Process validation and capability studies
** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and ensure compliance with regulatory standards in the medical device manufacturing sector. The ideal candidate will have over 10 years of experience in engineering roles, a strong understanding of industry regulations, and the ability to lead projects and teams effectively. **

Job Summary

  • This role provides strategic quality guidance to support the company's goals in medical device and battery manufacturing.
  • The successful candidate will lead regulatory inspections, manage non-conforming material processes, and ensure adherence to FDA regulations.
  • You will serve as a subject matter expert, mentoring up to five direct reports while driving continuous improvement initiatives.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and ensure compliance with regulatory standards in the medical device manufacturing sector. The ideal candidate will have over 10 years of experience in engineering roles, a strong understanding of industry regulations, and the ability to lead projects and teams effectively. **

Skills & Requirements

Must-have

  • 10+ years engineering experience
  • FDA regulations and QMS knowledge
  • Process validation and capability studies
  • Root cause analysis and CAPA management
  • Bill of Materials review expertise
  • Lead regulatory inspections and audits

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication
  • Mentoring and supervising engineers
  • Continuous improvement culture mindset

Key Requirements

  • Bachelor's degree in engineering required
  • 10+ years progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter