1, establish the "quality first" concept, adhere to the principle of quality and efficiency, undertake the specific work of quality management, quality management of medical devices, quality management, work quality management, the effective exercise of adjudication;
2, based on the enterprise quality policy objectives. Develop the department's quality work plan, and assist departmental leaders to organize and implement;
3, responsible for quality management documents in the implementation of the department, regularly check the implementation of the system, on the existence of problems to propose improvement measures, and make a good record;
4, the quality of the products of the business process of strict inspection and supervision, and regularly on the implementation of the enterprise's quality management work Inspection, assessment, the effective exercise of veto power 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 of the work of business and technical guidance;
8, is responsible for dealing with the medical device product quality complaints, quality inquiries ; fill in the quality of the customer to reflect the quality of the problem of quality query registration form, timely detection of the cause, rapid response to resolve, and organize the query by month to report to the quality of the person in charge;
9, is responsible for the management of quality information. 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 report of the audit and end-of-life medical device disposal supervision, do a good job of unqualified medical devices related records; 11, collection, storage of the department's quality information, archives, and supervise the positions to do a good job of all kinds of accounts, records, to ensure that the department of the completeness of the records of the quality of the activities, the accuracy and traceability;
12, to help Departmental leaders to organize the department's quality analysis meeting, make good records, fill in the quality of statistical reports and various types of information processing orders in a timely manner; 13, responsible for the collection of medical device adverse reaction information, processing and reporting work. Quality management personnel responsibilities:
1. Implementation of laws, regulations and administrative regulations relating to product quality management. 2.Draft the enterprise product quality management system, and guide and supervise the implementation of the system.
3. Exercise supervision and management in the purchase and purchase of products, inspection and acceptance, storage and maintenance, and transportation of medical devices, and exercise veto power over the quality of medical devices.
4. Responsible for the legitimacy and quality audit of the first enterprise and the first species.
5. Responsible for the establishment of the enterprise's products and contains quality standards and other content of the quality file. 6. Responsible for product quality inquiries and product quality accidents or quality complaints investigation and handling and reporting.
7. Responsible for the supervision and management work related to the inspection and acceptance of product warehousing, guidance and supervision of product storage, maintenance and transportation in the quality of work. 8.Responsible for the confirmation of quality unqualified products, and supervise the handling process of unqualified products. 9.Collect and analyze product quality information.
10. Assist in carrying out education or training on quality management for enterprise workers. 11. Other work related to quality management. Duties of quality inspection staff
1. Do a good job of inspection of the basic work, the development of the inspection staff's job responsibility system, and the strict implementation of the assessment system, and actively participate in the identification of new products, learning.
2. Establishment of the quality system account, the correct preparation of quality inspection reports, so that the account is 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.