Hybrid QA Lead Engineer – Medical Device QMS

GE HealthCare; Waukesha (WI); Hybrid; USD 110,000 - 140,000; Full time

Job summary

GE HealthCare is seeking an experienced Quality Assurance professional in Wisconsin to lead engineering processes and QMS management for the Patient Care Solutions business. This role focuses on design, design transfer, deployment of the QMS, and continuous improvement to ensure regulatory readiness and product quality.

The ideal candidate has a technical background, at least 3 years in a regulated environment, and strong collaboration skills to partner with global teams while maintaining high

Qualifications

• Bachelor’s degree in engineering or technical field or equivalent experience.
• Experience in regulated manufacturing/quality environments.
• Familiarity with FDA CFR 21 820 and ISO 13485.

Responsibilities

• Drive quality culture and total quality management across product/site/region.
• Ensure regulatory compliance and improve process effectiveness.
• Represent GE Healthcare to external agencies and lead quality objectives.
• Develop domain expertise and apply policy/strategy to tasks.
• Communicate design controls, CAPA, and risk management to teams.

Skills

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in engineering or technical discipline

High School Diploma with 7 years experience

Tools

QMS

Job description

GE HealthCare is seeking an experienced Quality Assurance professional in Wisconsin to lead engineering processes and QMS management for the Patient Care Solutions business. This role focuses on design, design transfer, deployment of the QMS, and continuous improvement to ensure regulatory readiness and product quality.

The ideal candidate has a technical background, at least 3 years in a regulated environment, and strong collaboration skills to partner with global teams while maintaining high