1、结合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；According to relevant regulations on post market quality management of medical devices ; Establish, maintain, and continuously improve post market quality system;
2、参与对客户投诉的评审，确保投诉评估和调查的完整、充分和及时；Participate in 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.
5、参与市场行动和产品召回的评估；Participating in evaluation to field action and product recall;
6、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;
7、参与药监部分和第三方机构的外部审计。Participate audits by regulatory authorities and third-parties
任职资格
1、6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经验者优先。 6+ years of experience in drug and/or medical device quality management; experience in high-risk class III medical devices is highly preferred.
2、熟悉医疗器械上市后质量管理和上市后监督相关的法规要求； Familiar with 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.