The qualifications of the quality officer or quality management personnel in the medical device business enterprise are crucial. First of all, they need to have an academic background in medical device related fields, such as college degree or above, or hold intermediate or above professional and technical titles. In addition, they should have at least 3 years of experience in quality management of medical device business, so as to ensure their in-depth understanding and practical experience in the industry.
According to the provisions of the Code for Quality Management of Medical Device Operation, enterprises should set up a quality management organization appropriate to the scale of operation or equip with corresponding professionals, who are required to have nationally recognized professional knowledge and titles. For the operation of Class III medical devices, the professional requirements for the person in charge of quality are even more stringent, requiring a college degree or intermediate title in the above professions, and the same need to have more than 3 years of relevant experience.
Enterprises also need to ensure that the person in charge of quality and all job holders receive training commensurate with their duties, including laws and regulations, professional knowledge, quality management system and operating procedures, and pass the examination before taking up their posts. The establishment of employee health records is also essential, especially for positions in direct contact with medical devices, such as quality management, receiving and inspection and warehouse management, and health checks are conducted at least once a year to ensure that the physical conditions of employees meet the job requirements.
Overall, quality management personnel in medical device business enterprises should not only have professional knowledge, but also practical experience, and need to continue to learn and maintain their health status to ensure the quality of products and services.