Senior Director, Site Quality, Waukesha South Operations

GE HealthCare UK

Waukesha, United States
Quality management system
Design quality
Production and process control
This role will be responsible for overall Quality Assurance activities at the Waukesha South Operations (WSO) facility, which designs and manufactures finished medical devices

Job Summary

  • This role will be responsible for overall Quality Assurance activities at the Waukesha South Operations (WSO) facility, which designs and manufactures finished medical devices.
  • The Senior Director will lead a team of quality professionals, drive compliance, ensure quality and regulatory compliance, and represent GE Healthcare to external agencies.
  • GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

Matching Summary

This role will be responsible for overall Quality Assurance activities at the Waukesha South Operations (WSO) facility, which designs and manufactures finished medical devices.

Skills & Requirements

Must-have

  • Quality Management System
  • Design Quality
  • Production and Process Control
  • Regulatory Compliance
  • Quality Culture
  • External Agency Representation

Nice-to-have

  • Thought Leadership
  • Cross-functional Team Leadership
  • Crisis Management Strategy
  • Global Working Environment Experience

Key Requirements

  • Bachelor's Degree or 14 years work experience
  • 10 years in regulated medical device or pharmaceutical industry
  • Medical Device QMS requirements
  • FDA CFR 21 820 and ISO 13485 knowledge
  • Design controls, V&V, CAPA, risk management expertise
  • Product development lifecycles understanding
  • Internal and external audit experience

Work Rights

Legally authorized to work in the United States

Tailored Resume

Cover Letter