Job responsibilities:
1, responsible for checking, supervising and evaluating the impact of 4MIE on products in each department, supervising the implementation of operation specifications, the implementation of the material protection requirements, the point inspection of the equipment, the use of the equipment, maintenance and so on.
2, responsible for qualified products into the warehouse release.
3, responsible for TCN/ECN/PCN implementation of follow-up, quality abnormalities in the report of the implementation of measures to follow up, the quality of regular meetings minutes follow-up.
4, familiar with the product production process, understand the key control points and requirements.
5, familiar with the production of 5 elements of management control, understanding of quality management improvement tools.
6, understanding of ISO13485, medical device production quality management standard on-site inspection guidelines and other regulations.
7, more than 1 year experience in the same position.