Sterility inspector

Job Responsibilities

1. Assist the quality manager to establish and improve the YY/T0287-2017 medical device quality management system and the management and maintenance of production activities and processes to ensure process and products meet the relevant standards and regulations. Continue to improve, and formulate the company's quality management system and supervise implementation.

2. Assist the quality manager to be responsible for product registration related work, responsible for the establishment and maintenance of quality systems, responsible for internal and external audits and quality training of internal personnel.

3. Regularly evaluate the operation of the quality system, and rectify and implement existing problems; assist in risk management activities and failure mode analysis to ensure compliance.

4. Maintain quality records and analysis, analyze and process the information and data obtained in the supervision process, and regularly count, organize, archive and report quality records.

5. Assist the quality manager to deal with the supervision department.

6. Assist the quality manager to be responsible for the company's quality control, check and organize the rectification of non-conformities found in the operation of the system; organize to accept the review of the medical device regulatory agency.

Job requirements

1. technical secondary degree or above, undergraduate recruitment.

2. Have more than two years of work experience in the same position in a medical device company.

3. Proficient in CFDA, familiar with GB/T19001-2008, YY/T0287-2017 medical device quality management system audit methods, audit requirements, GMP and other aspects.

4. Have the knowledge and experience of international certification of medical device manufacturers, and have the ISO13485 quality management system internal auditor certificate.

5. Have excellent communication and coordination skills, and have experience in dealing with regulatory authorities.