Provide quality and compliance support for the designated vendor and associated product complaint workflows, including monitoring activities and assisting with investigation and process requirements, including but not limited to the product complaint workflows/handling, product complaint investigations, maintaining unified product defect investigation operating procedures, maintaining and monitoring systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure, potentially reportable MDRs, returned goods authorizations, field alert reports, etc. As a Senior Product Complaint Operations Specialist, you will be at the center of end-to-end product complaint handling for devices, drugs, combination products, and biologics-helping ensure complaints, MDRs, malfunction reports, FARs, BPDRs, returned goods activities, investigations, and related quality system workflows are managed with accuracy, urgency, and care.