职位介绍

Job Responsibility:
1.Be responsible for the establishment, certification, maintenance, and improvement of QMS such as ISO13485 ,China GMP system.
2. Be responsible for supervision, inspection, correction, and continuous improvement of the quality management system.
3. Be responsible for collecting relevant laws and regulations to related medical devices and transferring them into internal implementation.
4. Prepare annual audit plan, be responsible for the company's external (customer, 3rd party or bureau inspection) audit, internal audit, management review and prepare audit report, follow up coordination and implementation of corrective and preventive measures.
5. Take full responsibility for CAPA system, track the handling of non-conforming items and correct preventive measures, and verify the effectiveness.
6. The company's quality system related documents archiving, quality system records collection and preservation.
7. Internal training and coach in quality awareness in the organizational
8．New laws and regulations, interpretation, internal communication, and training
9. Supervise the effective operation of the latest version of documents and documents by various departments, as well as the work items handed in by superiors.
Job requirements:
1.College degree and above;
2. Injection molding, product quality engineering, management engineering, biomedical engineering and other related professional.
3. 5 years and above 2 medical device industry quality system management experience, China’s medical device production quality management norms GMP; Has ISO13485:2016 version of the internal auditor certificate or NMPA registration experience is preferred.
4. Have a strong logical thinking and writing ability, can independently complete the company's quality management system document writing.
3097 5360-8|172 0019 7210 895. Good communication and coordination organization and problem-solving skills, a high degree of quality awareness and work responsibility, good team spirit.