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 within their organization, supporting the manufacturing of high-quality medical devices and niche batteries. The ideal candidate will possess extensive engineering experience, leadership skills, and a commitment to quality and continuous improvement. **

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while acting as an authority in the field.
  • 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 other engineers, supervise up to five direct reports, and drive continuous improvement projects.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance within their organization, supporting the manufacturing of high-quality medical devices and niche batteries. The ideal candidate will possess extensive engineering experience, leadership skills, and a commitment to quality and continuous improvement. **

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 methods and 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 skills
  • Experience with global customer base
  • Positive can-do attitude under pressure
  • Mentoring and coaching capabilities

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA regulations and QMS
  • Experience leading CAPA activities
  • Ability to work independently

Work Rights

Not specified

Tailored Resume

Cover Letter