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.