Principal Quality Engineer

Integer

Not specified (assumed office-based with potential for remote interaction with customers).
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 within the organization. The role emphasizes collaboration, innovation, and adherence to quality management systems, aiming to enhance product integrity and customer satisfaction in the medical device industry

Job Summary

  • This role provides strategic quality guidance to support Integer's goals while serving as a subject matter expert in medical device manufacturing.
  • The incumbent will lead regulatory and agency inspections, manage complaint investigations, and ensure compliance with FDA regulations and Quality Management Systems.
  • Candidates must possess over 10 years of progressive engineering experience and demonstrate the ability to work independently while collaborating with cross-functional teams.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization. The role emphasizes collaboration, innovation, and adherence to quality management systems, aiming to enhance product integrity and customer satisfaction in the medical device industry.

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

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO, UL, MDD, TGA standards awareness
  • Mentoring and coaching engineering teams
  • Global customer interaction experience
  • Continuous improvement methodology expertise

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • Knowledge of FDA and ISO regulations
  • Experience leading CAPA activities

Work Rights

Not specified

Tailored Resume

Cover Letter