Assist the company in formulating a comprehensive quality development strategy, guiding the establishment, operation, and continuous improvement of the quality management system.
Lead product registration and certification processes to ensure smooth passage of product inspections, supervision sampling, system assessments, and other related tasks.
Ensure compliance with regulations throughout the entire process from R&D to post-market supervision of products.
Fulfill any additional tasks assigned by superiors.
Job Requirements
Hold a Bachelor's degree or above with over 10 years of experience in quality management within the high-end medical device industry; possess more than 5 years of project/team management experience; previous work experience as a management agent or quality regulation leader is preferred.
Possess familiarity with relevant medical device regulations and GMP (Good Manufacturing Practice), ISO13485 quality management systems; have successfully undergone system verification, flight inspection, and external audits.
Be knowledgeable about the registration process for all three types of active medical devices.
Demonstrate strong abilities in communication and coordination, resource integration, problem-solving skills as well as emergency plan management.
