About this role
The purpose of the QA Post Market Specialist is to perform complaint handling activities to ensure regulatory compliance and customer satisfaction. This role coordinates and submits regulatory reports to FDA and Country/Regional competent authorities. Engaged in the receipt, documentation, investigation, and closure/resolution of customer complaints to ensure regulatory compliance (e.g., FDA, CMDR, ISO) and customer satisfaction. Adhering to all Advita procedures and requirements. Assesses complaint events for regulatory reporting requirements. Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes. Escalates high severity events and cases to Management. Supports the completion of complaint activities in line with department metrics and key performance indicators. Supports audits and audit requests for complaints. Assists with continuous improvement activities and/or special projects, as assigned. Assists in training complaint team members. Assists in updates or creation of procedures, work instructions, forms, reports and letter templates to standardize departmental processes. Knowing and applying Advita’s Quality System and any appropriate FDA and international standards. Assist and support other employees, teams, and sales personnel, as necessary.