Lead Quality Engineer, Final Acceptance Team Leader, Global Service

GE HealthCare

Oak Creek, Wisconsin, United States
Quality management system requirements
Fda 21 cfr part 820
Iso 13485
This role is responsible for Quality Assurance activities supporting medical device history record review, final acceptance, and product release

Job Summary

  • This role is responsible for Quality Assurance activities supporting medical device history record review, final acceptance, and product release.
  • GE HealthCare is a leading global medical technology and digital solutions innovator.
  • Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Matching Summary

This role is responsible for Quality Assurance activities supporting medical device history record review, final acceptance, and product release.

Skills & Requirements

Must-have

  • Quality Management System requirements
  • FDA 21 CFR Part 820
  • ISO 13485
  • risk management tools
  • lean processes
  • standard work

Nice-to-have

  • lead and implement change
  • collaboration, negotiation, conflict-resolution
  • conduct internal and external audits
  • global regulatory experience
  • direct interaction with regulators

Key Requirements

  • Bachelor's degree or 6 years relevant experience
  • 5 years experience in a regulated environment
  • Availability to start at 7:00 a.m. CST

Work Rights

Not specified

Tailored Resume

Cover Letter