Shaanxi | Xi'an | Yanta District- -
Years of working：
Junior high school
(1)Implementing and enforcing relevant laws,regulations,rules and standards of medical devices.
(2)Organize the establishment and implementation of quality management system suitable for the medical devices produced,and maintain their scientific,rational and effective operation,report to the person in charge of the enterprise on the operation of the quality management system and improvement needs.
(3)To formulate and organize the implementation of the audit plan of the enterprise quality management system,assist the person in charge of the enterprise to organize the management review according to the plan,prepare the audit report and report the results to the management.
(4)Organize the internal quality management training of medical devices in enterprises,improve the quality management ability of employees,and strengthen the sense of honesty and law-abiding of enterprises.
(5)When a manufacturing enterprise receives supervision and inspection from drug regulatory departments at all levels,it shall maintain communication with the inspection team,provide relevant information and information,and cooperate with the inspection work;in view of the problems found in the inspection,it shall organize relevant departments of the enterprise to rectify in time as required.
(6)Regularly organize enterprises to conduct comprehensive self-examination of the operation of the quality management system in accordance with the requirements of the"Standards for Quality Management of Medical Device Production",and submit annual self-examination reports to the drug regulatory departments of the provinces,autonomous regions and municipalities directly under the Central Government before the end of each year.
(1)Compliance with discipline and law,good professional ethics and no bad working record.
(2)Familiar with and able to correctly implement the relevant laws,regulations and regulations of the state,and trained in the relevant laws,regulations and standards of medical devices.
(3)Have YY/T 0287(ISO 13485)or GB/T19001(ISO 9001)internal auditor certificate,or have received the same level of systematic quality management system knowledge training.
(4)Familiar with the quality management of medical device production,have the professional skills to guide or supervise the implementation of the"Standards for Quality Management of Medical Device Production"by various departments of the enterprise and the ability to solve practical problems.
(5)Good organizational,communication and coordination skills.
(6)The managerial representative of the medical device manufacturing enterprise shall have a bachelor's degree or a technical title at or above the intermediate level of the medical device-related specialty,and at least three years'experience in quality management or production and technical management;at least five years'experience in quality management or production and technical management of the medical device;he shall be familiar with the product,production and quality management of the enterprise and shall be practised.Manager representatives who have proven to be competent in performing their duties may appropriately relax the requirements for relevant academic qualifications and titles.