The administrator is mainly responsible for:
1, first of all, we must establish the concept of "quality first", adhere to the principle of quality and efficiency, to undertake the specific work of quality management, quality management of medical devices, quality management, work quality management, the effective exercise of adjudication.
2, must be based on the enterprise quality policy objectives, the development of the quality of the department's work plan, and to assist the departmental leadership organization and implementation.
3, is responsible for quality management documents in the implementation of the department, regularly check the implementation of the system, the existence of problems proposed improvement measures, and make records.
4, the quality of products in the business process of strict inspection and supervision, regular inspection of the implementation of quality management work, assessment, effective exercise of the veto within the enterprise.
5, in the enterprise departments with the assistance of the quality of the enterprise training, education;
6, is responsible for the reported quality issues for review, confirmation, processing, tracking;?
7, is responsible for the product care work of the business technology to guide.
8, is responsible for dealing with medical device product quality complaints, quality inquiries; the quality problems reflected by the customer to fill out the quality query registration form, timely identification of the causes, and promptly respond to resolve, and organize the query on a monthly basis to report to the person in charge of quality.
9, responsible for quality information management. Often collect a variety of medical device information and a variety of opinions and suggestions about the quality of the organization to pass feedback, and regular statistical analysis.
10, is responsible for unqualified medical devices before the loss of audit and end-of-life medical device disposal supervision, make unqualified medical device related records.
11, collect and keep the quality information and files of the department, supervise the posts to make all kinds of accounts and records, and ensure the completeness, accuracy and traceability of the records of the quality activities of the department.
12, to assist departmental leaders to organize the quality of the department's analysis of the meeting, make a good record, fill out the quality of statistical reports and various types of information in a timely manner. ?
13, responsible for medical device adverse reaction information collection, processing and reporting.
Do a good job in the basic work of inspection, the development of inspection personnel's job responsibility system, and strict implementation of the assessment system, and actively participate in the identification of new products, learning. ?
2. Establishment of quality system accounts, the correct preparation of quality inspection reports, so that the accounts are consistent with the table, timely and accurate.
3. Regularly participate in the company's quality inspection and analysis will be put forward to rectify the problem, and do a good job of user letters and visits, there are problems to do timely feedback, everything has a record, and every piece has to be accounted for.