Serves as a Quality Assurance team member who performs Compliance driven support activities to ensure that Quality Management System requirements are met.• Supports review of procedural process and document change order approval process to ensure compliance with federal regulation industry standards. • Oversees and establishes timelines for periodic review of documented procedures, and collaborates with stakeholders to complete required updates within required regulatory timelines.• Facilitates corrective action activities related to assigned Compliance function projects through utilization of TrackWise, assuring completion of required tasks prior to phase due dates. • Assists in review process for global standards, regulations, and guidance documents associated with medical devices to assess, confirm, and maintain compliance to Quality Management System requirements.• Compiles and coordinates presentation materials for monthly and quarterly Quality System metric meetings, tracking open action items and retaining update Quality System records as needed.• Assists with all aspects of 3rd-party audits including coordination of support staff, document preparation, back-room support, and management of post audit assigned activities when Quality Management System issues were found.

Served as Quality Operations Change Management team member who led change strategy integration for marketed labeling materials, and SAP material processing system.• Facilitated operational change and development support of SAP electronic-route cards (inspection plans) for medical device materials, streamlining processes and enhancing efficiency in compliance with industry standards.• Trained on creating, maintaining, and retiring inspection plans in SAP database system, supporting Quality Control, Service, and Operations departments at global operating centers.• Analyzed SAP material Master Data elements for correctness of all materials received and distributed at global Novocure Operation Centers, contributing to data integrity and operational excellence.• Improved implementation of revisions in Veeva Vault system for direct-to-patient marketing material documentation, encompassing changes for both commercial and clinical materials, and ensuring more optimized review process.• Interacted with Purchasing and Suppliers weekly, assuring correct print material source files provided, and generating correct marketing material version.• Supported internal audits and annual TÜV Rheinland 3rd-party audit cycle, achieving effective process compliance globally, and strengthening business process when issues were found.

Conducted investigation / analysis, and recorded verified medical device related adverse event information into SAP and FDA regulatory databases.• Evaluated patient safety medical device complaint documentation and requested follow-up information within predetermined surveillance regulatory reporting timelines to certify all device issues captured.• Collaborated with healthcare professionals, reviewing, collecting, and monitoring data related to patient complaint information of reported medical events associated with medical device.• Examined and delivered 50 completed medical complaints in SAP database per week, ensuring required information data accuracy and correctness.• Prepared, processed, and submitted 20+ Medical Device Reports (MDR) to FDA, delivering within required regulatory timelines.• Enhanced documentation of adverse events associated with medical devices by scrutinizing patient medical records and confirming accurate capture of pertinent device-related information.• Assisted with monthly complaint adverse event data metrics spreadsheet report compilation and creation, allowing for visual representation of adverse event incidences, and enabling targeted risk mitigation prioritization.

Oversaw requests for data trending, reporting, and analysis related to infection prevention.• Maintained, and prepared infection control data, facilitating responses to federal (CMS / NHSN), state (MHDO), and hospital requests.• Administered respiratory protection program by completing fit testing, increasing compliance by >50% of clinical staff out of 1.4K employees within 6 months.• Identified process improvement opportunity, improving lab test screening and decreasing infection reporting by 33%.• Conducted daily rounds in all patient areas to monitor and discuss infection prevention with medical and non-medical staff, providing infection control education as needed.