Medical Device QA Lead & QMS Strategist

HC1316 GE Precision Healthcare LLC; Waukesha (WI); Hybrid; USD 90,000 - 120,000; Full time

Job summary

GE HealthCare seeks a Quality Engineering professional to lead QMS processes, support design transfer, and drive continuous improvement in a regulated medical devices environment. The role focuses on quality culture, metrics, and compliance across the Patient Care Solutions business.

The candidate will engage with external regulators, partner with global teams, and ensure robust processes for design controls, CAPA, and risk management while operating in a hybrid schedule at the Waukesha,

Qualifications

• Requires a degree in engineering/technical discipline or equivalent experience in manufacturing/quality roles.
• Understanding of Medical Device QMS and regulatory requirements (FDA CFR 21 820, ISO 13485).
• Experience with design, design transfer, and quality metrics in a regulated environment.

Responsibilities

• Drive a quality culture by overseeing the quality management system for the product/site/region.
• Ensure regulatory compliance and optimize process effectiveness and efficiency.
• Represent GE HealthCare to external agencies and lead quality objectives, metrics and reporting.
• Collaborate with global teams and partner with cross-functional stakeholders.

Skills

Quality management

Regulatory compliance

Analytical problem solving

Excellent communication

Cross-functional collaboration

Education

Bachelor's degree in engineering/technical discipline

High School Diploma + 7+ years in manufacturing/engineering/QA

Tools

QMS tools

Job description

GE HealthCare seeks a Quality Engineering professional to lead QMS processes, support design transfer, and drive continuous improvement in a regulated medical devices environment. The role focuses on quality culture, metrics, and compliance across the Patient Care Solutions business.

The candidate will engage with external regulators, partner with global teams, and ensure robust processes for design controls, CAPA, and risk management while operating in a hybrid schedule at the Waukesha,