- Establishes and maintains the company quality system and ensures its compliance with regulatory requirements at home and abroad;
- Organizes internal reviews on the company quality system on a regular basis to ensure its legal compliance;
- Organizes and implements management reviews of the company, tracks and closes the review output;
- Reviews the key supplier quality system and participates in risk-based supply chain management;
- Assists in the preparation of quality system materials in relation to product registration at home and abroad;
- Responsible for the management of related laws and regulations of medical device quality management system, including without limitation evaluation, update, training and execution of relevant quality system documents;
- Organizes and coordinates system certification inspection and external audit work of the company;
- Handles other tasks assigned by the supervisor.
- Holds a Bachelor’s degree or higher granted by full-time unified enrollment universities, and has over 5 years’ work experience in quality management of medical device manufacturing enterprises;
- Proficient in the Chinese laws and regulations for medical device manufacturing enterprises;
- Has experience in quality management of medical devices, capable of independently directing training of ISO13485 quality system and proficient in the creation and maintenance of related procedures and documents;
- Holds a certificate of ISO13485 Internal Auditor;
- Has good communication skills and a team spirit;
- Has good communication skills in English.
- Experience in the establishment and management of quality system for Class III active medical devices preferred;
- Experience in completely directing the evaluation on high risk medical device system preferred.