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Laboratory experience in a complaint management or QA/QC role required. Experience with medical devices preferred. 11. Experience in TrackWise preferred but not required

Responsible for capturing and recording product quality complaints (PQC) from call center into Quality Assurance (QA) database. Direct communication with complainants to secure product complaint samples and provide information about the product required for the investigation. Manage product replacement and/or reimbursement. Perform laboratory evaluation of customer-returned product. Process document-based investigations. Assist to identify and report complaint trends. Assist to define and track performance metrics. 1. As complaint information is received from the call center, enter accurately into QA database. If incorrect information is received, notify the appropriate customer/stakeholder to ensure information is accurate. 2. Assist to identify non-PQC’s which are returned to the originator with the reason why it is not a PQC and forwarded to the appropriate functional area, or tracked, as required. 3. Assist to identify complaints which require expedited review and are escalated to the sites and senior management immediately. 4. Communicate directly with complainant to secure product complaint samples and obtain more information/clarity about the complaint. 5. Clearly document communication with complainant in acknowledgement letters to complainant or “letters to file” as appropriate. 6. Communicate complaint issues requiring Legal involvement to management. 7. Manage product sample mailers to complainant. Address/facilitate resolution of issues associated with the mailer package. 8. Manage product replacement and/or reimbursement. 9. Perform laboratory evaluation of customer-returned products and write evaluation report. 10. Perform document-based investigation in the QA database. 11. Finish complaints in the QA database and send final letters to complainant explaining the outcome of the investigation if required. 12. Assist to identify and report complaint trends by analyzing the data in the QA database. 13. Assist to define and track performance metrics to assure compliance processing complaints. 14. Required to enter and work in areas responsible for the handling of laboratory waste and blood borne pathogens.

Demonstrated experience with complaint processing" (especially customer-facing activities).

This job is with one of my Medical/Pharma Client.