Job Responsibilities:

1. Strategic planning and construction of medical device system: Based on the company's development goals and regulatory requirements (such as ISO 13485, NMPA/GMP, FDA QSR820, etc.), lead the overall design, construction, and upgrading of the quality management system, and develop medium - and long-term plans for system construction;

2. Operation and management of medical device system: Coordinate the preparation, approval, distribution, and updating of management system documents (such as quality manuals, procedure documents, work instructions, etc.) to ensure their suitability and implementation; Supervise the implementation of various departmental systems and solve coordination issues in the operation of cross departmental systems;

3. Compliance and risk management: Track domestic and international medical device regulations, standards, and industry trends, and promote enterprise compliance strategy adjustments; Organize full lifecycle risk management (design and development, production, warehousing, after-sales, etc.), lead risk assessment and implementation of improvement measures, and respond to regulatory inspections (such as flight inspections and system verifications);

4. Audit and Improvement: Plan and organize internal audits and management reviews, coordinate external audits (such as certification audits and customer audits), analyze issues identified during audits, drive corrective actions, and verify effectiveness;

5. Team management and empowerment: Lead the team to carry out work, clarify job responsibilities and goals; Develop a training plan to provide systematic knowledge, regulatory requirements, and other training to all employees, in order to enhance the overall quality awareness of the enterprise;

6. Cross departmental collaboration: Work closely with departments such as research and development, production, registration, and sales to ensure that system requirements are integrated into various business processes and promote the achievement of quality objectives throughout the entire process.

Job Requirements:

1. Bachelor's degree or above, major in Biomedical Engineering, Medical Devices, Pharmacy, Quality Management, or related fields;

2. Have at least 5 years of experience in quality management or medical device system related work in the medical device industry, familiar with the entire process of system construction and certification (such as ISO 13485, FDA QSR820, etc.);

3. Strong problem-solving skills, communication and coordination abilities, and leadership skills, rigorous and meticulous, with good stress resistance.