Sr. Quality engineer(IVD reagent)

- 负责确保IVD产品的设计/生产转移活动，以满足国内药监局（NMPA）等设计控制要求。

- 主导风险管理活动，包括推动风险管理档案的建立、审查和更新。

- 负责原材料、工艺和成品等过程的不合格/偏差/变更/CAPA，并协调当地质量评审委员会的活动。

- 负责为生产、技术、工程等其他跨职能团队提供质量保证支持，确保各项活动符合质量管理体系要求和国内法规等要求。

- 负责提供质量法规或产品知识技能等培训， 以提高员工的质量法规意识与技能水平。

- 负责支持产品拟上市与生产许可证的审核准备，以及现场审核和后续整改的支持工作。

- 负责产品的最终放行。

- 负责产品上市后监管活动，包括产品投诉、忠告性通知/产品信息告知、不良事件报告（含定期风险评价报告）、召回等。

- 负责完成上级或公司指派的其他相关项目或任务。

- Responsible for ensuring design/manufacturing transfer activities for IVD products to meet design control requirements such as the National Medical Products Agency (NMPA).

- Lead risk management activities including driving the creation, review and update of risk management files.

- Responsible for nonconformities/deviations/changes/ CAPAs for processes such as raw materials, processes and finished products, and coordinates the activities of the local Quality Review Board.

- Responsible for providing quality assurance support to other cross-functional teams such as production, technology, engineering, etc. to ensure that activities are in compliance with QMS requirements and domestic regulations, etc.

-  Responsible for providing training on quality regulations or product knowledge and skills to improve employees' awareness of quality regulations and skills.

-  Responsible for supporting the preparation of products to be marketed and production license audits, as well as on-site audits and subsequent corrective actions.

- Responsible for final product release.

- Responsible for post-market regulatory activities, including product complaints, advisory notices/product information notification, adverse event reports (including periodic risk assessment reports), recalls, etc.

- Responsible for completing other related projects or tasks assigned by supervisor or the company.