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