Senior Product Complaint Analyst
CurrentManaged and maintained complaint handling program for one of two divisions of the company. This included receiving, reviewing, evaluating, and maintaining complaints per QSR and ISO standards.Identified, prepared, submitted, and maintained electronic Medical Device Reports to the FDA following FDA requirements. Chaired monthly complaint review meeting. Conducted data analysis, prepared complaint handling report and meeting minutes and delivered the information to the necessary individuals within the company. Notified suppliers of complaints per corresponding Technical Agreement/Quality Agreement. Generated and distributed monthly vendor reports to corresponding vendors and coordinated special shipments for complaint investigations.Conducted data analysis and developed and prepared reports for management review and AOD. Generated MDR and complaint data analysis as required by management for risk review or other activities.Supported Product/Project Launches by coordinating and maintaining Quality Plans per QSR and ISO standards. Ensured all complaint handling systems, procedures and records comply with QSR and ISO standards.Participated in monthly Analysis of Data and Safety Management Team meetings.Participated in FDA and ISO audits as required.