Stacy Higgins

Responsible for review, assessment, coding and reporting of adverse events for class II device malfunctions in alignment with 21 CFR 803 & working knowledge of FDA regulations, ISO 13485. Responsible for global PSR reporting. Assisted with CVR/MIR reporting. Review lab assessment for follow up and initial device reporting. Reviewed customer calls via Amazon Connect to obtain additional information for required good faith efforts to ensure completeness before report filings. Worked with customer support, engineering, and quality teams to gather required details and improve complaint handling workflows. Perform Salesforce lookups and updates to maintain accurate complaint data and reporting readiness. Contributed to cross-functional brainstorming sessions to enhance complaint handling and investigation lab processes. Trained and mentored new employees on complaint handling procedures as well as QMS. Created and maintained GPM Smartsheet with product support team in order to track customer good faith efforts. Contributed to departmental non-conformances escalations to CAPA system. Served as subject matter expert to post market complaints handling team members.

• Evaluated, investigated, tracked, and completed complaints for nutritional feeding and deep vein thrombosis medical equipment. Ensured accurate documentation of evaluation and investigation results within complaint records. Identified product characteristics and failures that could lead to serious injury or death. Reviewed complaints to determine MDR/MIR/CVR/PSR reporting eligibility. Prepared billing documentation for Mitek and Codman Surgical Neuro and Visualization equipment. Provided technical assistance to Sales Representatives and Biomed customers. Performed return equipment follow-up, tracking, and complaint investigations. Assisted with MDR/MDV submissions and documentation. Managed software upgrade projects for Codman equipment. Monitored S&R complaint inboxes and performed SharePoint administration duties. Tracked equipment movement and coordinated contract item returns and reconciliation.

Prepared billing documentation for Mitek and Codman Surgical Neuro and Visualization equipment. Provided technical assistance to Sales Representatives and Biomed customers. Performed return equipment follow-up, tracking, and complaint investigations. Assisted with MDR/MDV submissions and documentation. Managed software upgrade projects for Codman equipment. Monitored S&R complaint inboxes and performed SharePoint administration duties. Collaborated with Codman and Mitek complaint handling teams for MDR/MDV/MIR and PSR reporting. Tracked equipment movement and coordinated contract item returns and reconciliation. Entered repairs and complaint evaluations into tracking systems. Worked with service centers, affiliates, customers, and third-party vendors. Processed repairs for medical instruments including drills and sheaths