Essential Job Functions % of time
Interpret Local Post market Regulation Requirements, Establish and maintain the effective complaint handling process, MDR process and FCA Process, under Edwards Quality Management System, in compliance with local regulations 20%
Receive and report complaints to Global team. Follow up compliant investigation and prepare customer responses and ad hoc reports 20%
Act as Field Corrective Action coordinator in Great China and ensure on time execution on FCA 15%
Be responsible for MDR. Assess the potential reportable complaints and report to Competency Authority within required timeline 20%
Organize and conduct training programs for Complaint Handling/MDR/FCA, ensure concerning functions/parties understand Edwards’ requirements on complaint handling. 15%
Will collaborate with Irvine BU Quality, Product Safety, Engineering and other departments/business units on complaint investigations and process improvements 5%
Tracking processes and report out using KPI and dashboard 5%
Marginal Job Functions
Under the direction of department management, is an active participant during internal and external audits
Perform periodic audits of complaints to ensure compliance to departmental procedures and all applicable government regulations
Other incidental duties
支持大中华区+亚太区的质量管理
主要是处理后市场的不良事件、投诉分析、风险评估。不涉及仓库。
要求：
本科或以上学历
主要看医疗行业（医疗设备或者医药）
3-10年相关工作经验
英语口语流利，需要汇报给印度人。