Principal Quality Engineer

Integer

**
10+ years progressive engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
** Integer is seeking a Principal Quality Engineer with over 10 years of engineering experience to provide strategic quality guidance within a culture of collaboration, innovation, and integrity. The role requires expertise in quality management systems, regulatory compliance, and process improvement to enhance product quality and support manufacturing excellence. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals in the medical device and energy battery sectors.
  • The incumbent will lead regulatory inspections, manage complaint investigations, and ensure compliance with FDA regulations and Quality Management Systems.
  • As a subject matter expert, you will mentor engineers, supervise direct reports, and drive continuous improvement projects across global operations.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer with over 10 years of engineering experience to provide strategic quality guidance within a culture of collaboration, innovation, and integrity. The role requires expertise in quality management systems, regulatory compliance, and process improvement to enhance product quality and support manufacturing excellence. **

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • 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 and international standards awareness
  • Mentorship and coaching capabilities
  • Global customer interaction skills
  • Continuous improvement mindset

Key Requirements

  • Bachelor's degree in engineering or related field
  • 10+ years of 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