Be responsible for the collection, review and filing of batch records to ensure that production documents comply with predefined specifications; Review abnormal situations in production documents, such as deviation, non-conforming products or change control records, and register problems and feed back to relevant departments for rectification; Review Design History Records (DHR) to prove that products are produced in accordance with specifications, and support FDA factory inspection or market release decisions; Follow up the inquiry and report of adverse events, and compile regular risk reports; Participate in internal audits or external audits, and provide batch records as compliance evidence; Coordinate cross-departmental rectification to ensure that production processes comply with regulatory requirements.

Have more than 3 years of experience in quality system construction and management in the medical device industry, be familiar with ISO13485 or ISO9001 standards, and have participated in quality management system assessment and product certification; College degree or above, priority is given to majors related to medical devices such as machinery, electronics, testing, biomedical engineering, and priority is given to those with internal auditor qualification certificate;