Senior QMS Program Manager

Job Description SummaryOwn the China-side deployment of the global CT R&D quality management system: translate global QMS requirements into executable China processes, and ensure China R&D, registration, and manufacturing activities meet NMPA and international regulatory requirements.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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.
Job Description
Roles and Responsibilities
QMS Operations — Establish, maintain, and continuously improve the China QMS, covering ISO 13485, NMPA GMP for Medical Devices and its annexes, 21 CFR 820, and EU MDR/MDSAP requirements.
Global Alignment — Partner with global Quality, Regulatory, and R&D teams; perform regulatory gap analyses; localize global QMS documentation and manage deviations.
Audits & Inspections — Lead preparation, hosting, and response for NMPA registration QMS inspections, unannounced inspections, internal audits, and third-party audits; drive nonconformity closure.
Design & Development Quality — Provide quality oversight of design controls (DHF/DMR), design reviews, V&V, design change, and design transfer for CT products.
Lifecycle Quality — Manage supplier quality, change control, deviations and nonconforming product, CAPA, management review, and post-market surveillance (complaints, adverse events, recalls, PSUR).
Quality Culture — Deliver QMS training and awareness programs; monitor China quality KPIs and lead improvement initiatives.
Requirements
Bachelor's degree or above in Biomedical Engineering, Mechanical, Electrical, Automation, or a related field.
8+ years of medical device QMS experience; medical imaging (CT/MR/XR) or large active-device R&D quality experience preferred.
Strong knowledge of the full NMPA registration and QMS inspection process; certified ISO 13485 internal auditor; hands-on audit-hosting experience.
English as a working language; able to collaborate with global teams across time zones.
Strong cross-functional influencing skills and documentation/process-design capability.
Preferred Qualifications
QMS practice for AI/ML-enabled medical devices
Six Sigma / Lean improvement project experience
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
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. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Additional Information
Relocation Assistance Provided: No