Lead Quality Engineer, Final Acceptance Team Leader, Global Service

GE HealthCare • Oak Creek, WI

20d

About The Position

This role is responsible for Quality Assurance activities supporting medical device history record review, final acceptance, and product release. The position ensures products meet capability and specification requirements while maintaining systems, processes, and standards that satisfy both internal and external expectations. It requires a strong understanding of business drivers and collaboration across teams to support site and organizational goals. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Requirements

• Bachelor’s degree from an accredited institution, or a minimum of 6 years of relevant experience in the medical device or similarly regulated industry.
• At least 5 years of experience in a regulated environment.
• Requires availability to start at 7:00 a.m. CST.

Nice To Haves

• Strong understanding of Medical Device Quality Management System requirements and regulations, including FDA 21 CFR Part 820 and ISO 13485.
• Excellent verbal and written communication skills.
• Demonstrated ability to lead and implement change.
• Proficiency with digital workflows and IT systems.
• Strong collaboration, negotiation, conflict‑resolution, and leadership capability.
• Experience conducting internal and external audits.
• Ability to prioritize and manage projects effectively.
• Exceptional analytical, problem-solving, and root‑cause analysis skills.
• Strong technical aptitude, including the ability to interpret technical documentation and execute procedures; global regulatory experience and direct interaction with regulators are a plus.

Responsibilities

• Provide guidance to team members by facilitating issue resolution, resource planning, coaching, mentoring, and career development.
• Develop, communicate, and execute strategies that ensure regulatory and quality compliance.
• Lead the creation, implementation, and ongoing optimization of effective and efficient site processes.
• Represent GE HealthCare during interactions with external agencies and promote a strong quality culture through quality objectives, metrics, reporting, and operating mechanisms.
• Support continuous product and process improvement through detailed analysis of nonconformances, and lead investigations and implementation of corrective and preventive actions (CAPA).
• Apply risk management tools—including PFMEA, Fault Tree Analysis, and Failure Mode Analysis—in alignment with documented procedures.
• Drive adoption of lean processes and standard work.
• Use technical expertise and sound judgment to solve complex problems, leveraging cross-functional partners as needed.
• Communicate complex information clearly and effectively with peers and leadership.
• Perform diverse tasks supporting product and process design activities.

Benefits

• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.
• GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
• GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.
• Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
• While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level