Supervisor, Product Investigation
Create, review, and modify procedures to streamline workload; increase efficiency and decrease the turnaround time necessary for the processing of customer complaintsDemonstrate awareness of device defects that may occur in area of responsibility, including product design, verification and validation, manufacturing and testing activitiesAdvise management on the required staffing levels to maintain desired customer response levelsAssess customer complaints for Medical Device Reporting requirements; Identify and escalate cases with potential regulatory actions; Advise management of significant product issues and unresolved customer issuesReview complaint investigations for completeness and compliance with applicable regulationsEnsure prompt attention in areas of risk, which may have an adverse effect on product quality/performance, product completion and/or safetyApply standard problem-solving tools; recommend corrective actionHandle multiple priorities on daily basis; Use time management skills to be productive and deliver positive, concrete resultsTrack and review daily indices and metrics, and recommend area of focus, raise issues to appropriate level for resolution, recognize and quantify risk, collect and analyze customer feedback