1、Organize carry out the operation of regulations on supervision management to medical instruments the medical devices regulations quality standards, to comply the relevant requirements;
2、Responsible fdrafting, drawing up revising company quality management system, duties, operation process according to the State of the medical device law, regulations the company''s strategic objectives, to perform the guidance.
3、To push the construction of quality system, To operate company quality management system according to the company''s policies objectives, plans, strategies, etc.
4、Assist in registering CFDA of company products.
5、To set up improve 13485 quality management system documents.
6、Supervise guide to establish the information of quality analysis documentation. Assist in operating ISO9001
7、Participation on the employees’ training of GMP organization implementation of GMP.
8、To participate in preliminary research development of product, to do collaboration cohesion between development registration.
9、Leading department coordinate with related departments to carryout quality audits (product audits process audits), continuously improve product quality process quality
10、To organize assessment guidance of training of regulatory business fQA & QC inspectors.
11、To supervise operation of system ensure the functioning of quality management system with regulatory requirements also can be applied to actual production
12、Regular safety study required skill training
13、With various way to keep good working conditions motivation of employees, increase cohesion between departments, improve satisfaction rate of employees.
14、Collect clients’ feedback information handling clients’ complains; Improve rate of customer satisfaction.
15、Complete other assignments by GM