工作职责
1、组织收集医疗器械上市后质量管理相关的法律、法规等有关规定；建立、维护和持续改进后市场相关程序；Organize the collection of relevant regulations on post market quality management of medical devices ; Establish, maintain, and continuously improve post market quality system;

2、负责对客户投诉的评审，确保投诉评估和调查的完整、充分和及时；Responsible for reviewing customer complaints, ensuring the completeness, adequacy, and timeliness of complaint evaluation and investigation;

3、参与对客户投诉相关的纠正预防措施的评审，跟踪相关措施的执行及有效性评估；Participate in the review of corrective and preventive actions related to customer complaints, track the implementation and effectiveness evaluation;

4、负责组织、审核或批准后市场监督相关文档，确保其完整性、准确性和及时性，并符合主管药监部门的法规要求。Responsible for organizing, reviewing, or approving PMS documents, ensuring completeness, accuracy, and in-time to meet regulatory requirements.

5、负责定期和及时沟通用户反馈及PMS数据和/或趋势分析，组织相关职能部门确定改进机会，并推动持续改进。Responsible for timely communication of customer feedback and PMS data and/or trend analysis, organizing relevant functional departments to identify improvement opportunities, and promoting continuous improvement.

6、负责管理健康危害评估(HHE)流程，参与市场行动和产品召回的评估。并定期组织对后市场风险进行评估以做出基于风险的决策；Responsible for managing the Health Hazard Assessment (HHE) process, participating in evaluation to field action and product recall. Organize periodical assessments of post market risks to make risk-based decisions;

7、参与不良事件的评估、调查和报告过程；Participate in the evaluation, investigation, and reporting process of adverse events;

8、作为后市场质量的负责人，独立应对药监部分和第三方机构的外部审计。Functional SME to external audits by regulatory authorities and third-parties.

任职资格
1、10年以上药品和或医疗器械质量管理经验；有第三类高风险医疗器械上市后质量管理经验者优先。 10+ years of experience in drug and/or medical device quality management; experience in high-risk class III medical devices is highly preferred.

2、精通医疗器械上市后质量管理和上市后监督相关的法规要求； Expertise in PMS management of medical devices;

3、6-sigma绿带优先，尤其是对趋势分析、方差分析、抽样理论等质量工具的应用。6-sigma green belt preferred, particulaly in trending analysis, variance analysis and sampling.

4、出色的团队沟通和协调能力. Excellent team communication and coordination skills.

其他信息
语言要求：英语、普通话

所属部门：质量部