Essential Job Functions 61 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 61 Receive and report complaints to Global team. Follow up compliant investigation and prepare customer responses and ad hoc reports 61 Act as Field Corrective Action coordinator in Great China and ensure on time execution on FCA 61 Be responsible for MDR. Assess the potential reportable complaints and report to Competency Authority within required timeline 61 Organize and conduct training programs for Complaint Handling/MDR/FCA, ensure concerning functions/parties understand Edwards’ requirements on complaint handling. 61 Will collaborate with Irvine BU Quality, Product Safety, Engineering and other departments/business units on complaint investigations and process improvements 61 Tracking processes and report out using KPI and dashboard Marginal Job Functions 61 Under the direction of department management, is an active participant during internal and external audits 61 Perform periodic audits of complaints to ensure compliance to departmental procedures and all applicable government regulations 61 Other incidental duties
