Position summary:
Lead the China NV QA team to build and maintain a compliant, effective and inspection-ready Quality Management System that safeguards patient safety and supports NV business growth. Ensure every product released in China meets China regulations and Stryker requirements.
Essential Duties & Responsibilities: (Detailed Description)
Develop annual QA strategy, budget and resource plan aligned with business needs and NMPA focus areas.
Build, defend and continuously improve a best-in-class Quality Management System covering the full product life-cycle.
Build and mentor a high-performing team capable of hosting unannounced NMPA inspections at both local and overseas sites.
Lead the NV team to pass both domestic and overseas NMPA inspections with minimal business disruption.
Establish proactive post-market surveillance programs for NV products, especially for VBP products; drive trending and risk-benefit reassessments.
Review, analyze and report quality discrepancies; author dispositions and corrective actions for recurring issues.
Support Operations and third-party warehouse management to ensure compliant product distribution and sales.
Serve as primary interface with NMPA, provincial bureaus, and global QA/RA functions; maintain credibility and rapid escalation paths.
Anticipate regulatory changes (e.g. random inspection for VBP products, overseas facility audits) and implement preventive actions before mandates take effect.
Plan, execute and monitor the QA team objectives; track KPI closure rates.
Own the local QA budget.
Complete other assignments as directed by senior management.
Education & Experience:
Bachelor’s degree or above in Biomedical Engineering, Pharmacy, Mechanical Engineering or related field.
8 + years of progressive QA experience in interventional/implantable medical devices, including 3 + years leading teams.
In-depth knowledge of NMPA regulation, such as ISO 13485, GMP.
Proven track record of successfully hosting NMPA targeted or unannounced inspections.
Fluent English (written & spoken) for global collaboration.
Physical & Mental Requirements:
Well-organized and logical thinking
Good at strategy making
Detailed oriented
Professional communication skills
Team player
Patience and a great sense of responsibility
Leadership (People Management requirement)
Allocate workload, set objectives, coach and develop QA team.
Identify training needs and succession plans aligned with Performance Management.
Manage cross-functional projects.
Travel Percentage: None