Quality Supervisor

Job Responsibilities:
1. Establish a quality management system for cell therapy related products and continuously improve it;
2. Responsible for the company's ISO9001 and ISO13485 quality system certification and operation maintenance;
3. Release of raw materials and batch product quality;
4. Cooperate with clients for on-site audit work;
5. Responsible for providing quality management system training to various departments;
6. Cooperate with the supervision and inspection of higher-level management departments, third-party audit agencies, and organize internal audits to track and audit rectification projects, implement corrective/preventive measures for improvement items;
7. Responsible for a portion of QC testing experiments;
8. Complete other related tasks arranged by the company.

Job requirements:
1. Bachelor's degree or above in a related field, with at least 3 years of work experience in quality system management in the cell therapy and medical device industries;
2. Experience in ISO 9001 and ISO 13485 system management, with prior experience in conducting audits preferred;
3. Experience in writing and revising system documents is preferred;
4. Ability to inspect, train, guide, and promote the operation of the quality management system;
5. Has good communication and learning skills, team spirit, and certain pressure bearing ability;
6. Have some experience in QC experimental testing (sterility, endotoxins, osmotic pressure, pH, etc.).