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该职位主要负责有效执行客户投诉管理流程，协调、跟踪客户反馈调查进程，投诉报告及不良事件的处理，跟进改进事项，确保有效关闭；负责应对内部和外部审核以确保上市后相关的质量体系的法规符合性。 确保（PMS）上市后质量体系流程规范符合医疗器械行业标准,例如现行China GSP& GMP, ISO的要求。
The role of Quality Assurance Engineer is to ensure customer complaints handling effectively, including, coordinate, follow up investigation progress of customer feedback, complaints report and adverse events handling, follow-up on improvement items to ensure them closed effectively. And responsible for internal and external audits, to ensure PMS quality system regulatory compliance.
Ensure PMS QMS procedures compliance to the requirements of medical device regulations and standards, such as China GSP&GMP, ISO.
负责上市后客户反馈，投诉处理、上报、不良事件处理和相关网站信息维护更新。Responsible for post market complaint handling, reporting, adverse event handling and related information maintenance in designated website.
负责对上市后质量数据进行收集和分析，作出初步判断是否需要上报不良事件，或升级至CAPA，改善措施，市场措施等情形。
Responsible for collecting and analyzing post-marketing quality data and making preliminary judgments on whether adverse events need to be reported, or escalated to CAPA, improvement measures, field action, or other situations.
协同各职能部门对上市后的反馈、投诉、不良事件等进行调查、分析、改进，并形成调查报告。
Collaborate with functional departments to conduct Investigation, analysis, and improvement for post-market feedback, complaints, and adverse events, and complete investigation reports.
负责月度质量改进会议中上市后反馈部分的数据分析和报告。
Responsible for QAISR post market feedback relevant data analysis and report.
参与和支持内外审、质量最佳管理规范、流程提升的有效性；
Participate and support external and internal audits.
经理安排的其他任务。
Other tasks assigned by manager.
职责还包括Responsibilities also include:
(1)从事日常专业活动Performing routine professional-based activities
(2) 参与和管理持续改进项目Contributing to and managing projects of continuous improvement
(3) 在主要专业领域提供建议/指导Providing advice/direction in primary areas of expertise
(4) 利用专业知识和关系为战略做出贡献，推动业务结果Leveraging professional expertise and relationships to contribute to strategy and drive business results
在自己的专业领域与内部和外部高级利益相关者建立有效网络和协作Effective Networks and collaboration with senior internal and external stakeholders in own area of expertise.
需要时对初级/新入职人员提供PMS质量培训。Provide PMS quality training to junior and/or new staff when needed.
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学士学位或以上，并具备医疗器械质量工作资历相关专业（生物，医学，机械，材料科学，电气,电子，化学等）。Bachelor’s degree or above with major of medical device quality relevant (majors of biomedical, medicine, mechanical, material science, electrical, electronic, chemistry, etc.).
至少3年医疗器械行业经验。熟悉中国GSP, GMP和ISO 13485要求。Minimum of 3 years of related experience in medical device. And familiar with China GSP, GMP and ISO 13485.
对所针对的质量问题和不良事件作出有效评估和调查结论及处理意见。Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
组织跨部门团队进行质量改进，需要时能支持、指导团队解决质量问题。
To organize cross function team to do quality improvement，give the support and guidance to do problem solving when necessary.
在质量相关的专业领域能具备所要求的基本知识，技能，原则和理念。Performs work in a specialized area of expertise that requires knowledge of fundamental themes, skills, principles and concepts.
语言：汉语母语，英语流利，能保证其与公司内外部的利益相关方的有效沟通和协作。
Languages: Mandarin Chinese is native language; Fluent English both in writing and speaking to collaborate with relevant global stakeholders, as a working language.
良好的沟通能力，注重团队合作，自我驱动，并且能够独立工作。
Good communication skills, teamwork orientated, self-motivated and able to work independently
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!