质量管理总监/经理/主管

该职位来源于猎聘 Objective Serving as the Management Representative, QA manager should lead the establishment, implementation and continuous operation of the GMP quality management system for the China factory. Responsible for full-range quality management including QMS, document control, risk management, CAPA, design transfer docking, Domestic regulatory compliance, as well as post-market surveillance and vigilance system management. Ensure the products and processes continuously comply with NMPA regulations and TMS. Responsibilities

• Manage the daily maintenance, internal audit and continuous improvement of ISO13485 QMS for Marketing Unit.
• Lead the 0-1 establishment and implementation of the GMP for the China factory.
• Establish end-to-end quality risk management, and oversee all types of quality deviations, process non-conformities, system anomalies and CAPA activities.
• Manage quality reviews and controls for design transfer via cross-functional interface. Verify the completeness, accuracy and compliance of R&D outputs, production processes and quality specifications, ensuring stable mass production quality and regulatory compliance.
• Liaise with external testing institutions, certification bodies and regulatory authorities to ensure smooth completion of certifications and audits.
• Conduct full-process quality control and supervision for the R&D and production of medical device projects throughout the entire product lifecycle.
• Undertake other quality management tasks assigned by superiors and continuously optimize quality management processes and system efficiency.