QA Manager
Core
Manage quality assurance for Cytiva's medical device localization projects in China, ensuring compliance with local regulations and maintaining the Quality Management System.
Role type
Senior IC QA Manager (Medical Devices)
Builds
Medical device localization projects and compliant quality systems for the China market
Domain
Life Sciences / Medical Devices / Regulatory Compliance (China)
Required skills
GSP compliance, GMP knowledge, ISO9001/13485 familiarity, post-market QA, audit management, CAPA management, Quality Agreement (QAA) review, problem solving
Preferred skills
Internal auditor qualification (ISO9001/13485), cross-functional collaboration
Technologies
GSP, GMP, ISO9001, ISO13485, QMS
Responsibilities
Manage GSP-related policy and compliance affairs for Cytiva medical devices; Support localization projects from a quality perspective; Lead or contribute to post-market QA activities and internal/external audits; Provide and review Quality Agreements (QAA) for commercial teams and customers
Seniority
Senior, hands-on IC