1. Responsible for confirming the company's quality management plan, quality system strategy, and overall planning;
2. Responsible for the implementation, maintenance, and improvement of the company's quality system, and monitoring its effective operation;
3. Responsible for coordinating external audits such as ISO13485, GMP, CE, etc., promoting the rectification and tracking of audit issues, ensuring timely closure of identified items, and ensuring that the company smoothly passes various external quality audits;
4. Organize internal audit, daily patrol inspection and other work according to ISO13485GMPCE and other standards, and promote the rectification of problems found;
5. Responsible for coordinating quality system changes to ensure orderly and controllable changes;
6. Responsible for external declaration work;
7. Cooperate with the quality system support work during the product registration process;
8. Responsible for coordinating business cooperation with other departments;
9. Responsible for completing other tasks assigned by superiors.
1. Bachelor degree or above, major in quality management, chemistry, biology, microbiology, pharmacy, medicine and other related fields is preferred;
2. At least 5 years of experience in the quality management system of drug or medical device production, and at least 3 years of team management experience;
3. Familiar with ISO13485 and qualified as an internal auditor; Or familiar with the quality management standards for implantable medical device production; Or familiar with the requirements of animal source standards; Candidates with CE certification experience are preferred;
4. Proficient in using Microsoft Office application software; Proficient in English, excellent listening, speaking, reading, and writing skills; Good communication, collaboration, and problem-solving skills; Strong learning ability and meticulous logic; Proactive in work, with strong motivation and sense of responsibility; Possess clear written and oral communication skills.