FDA Regulations 21 CFR Part 11, 210, 211, 820, cGxP, GAMP 5, ISO 13485, ISO 14971, Health Canada, EU PIC/S Annex 11, EU MDD directives, CE mark, 510(k), Data Integrity, Cyber Security, Cloud Computing, SaaS, Design Controls, Design V&V, QMS, FMEA, CAPAs, Change Controls, Defect Tracking, NCR, Audit Trails, Technical Writing, Change Management, SOP Development, GAP Assessment, Verification/Validation, Risk Assessment & Management, Regulatory Compliance, Oracle, MS SQL Server, PL/SQL, SharePoint, MS Office (Word, Excel, PowerPoint, Access), MS Project, Outlook, Visio, Google Docs, Sheets, Slides, HP Quality Center (ALM) software suite, EtQ, DOORS, Windows OS, SDLC, Waterfall, Agile, Scrum, PACS, DICOM, VMware products

• Conducted equipment Validation/integration between Fujifilm Synapse PACS, Synapse Cardiovascular and 3rd party vendors.• Maintained lab environment validated and up to date through Server virtualization by setting up all types of VM’s and upgrades with latest software updates across all Fujifilm implementation products and Storage Archiving systems.• Develop, update test Protocols, and document test results in accordance with Quality Assurance Control compliance and regulatory management criteria.• Worked with engineering on process development and product customization management.• Synapse Mobility validation with Fujifilm PACS, CV, and VNA.• Work as a team with sales, Marketing, engineering and outside vendors to evaluate new hardware solutions and come up with the best cost saving configurations for the entire Fujifilm Enterprise products. • Comfortable in setup and troubleshooting of various IT related systems including Servers, SAN, and LAN, WAN.• Experience working with database setup and structure in Synapse PACS and SQL in Synapse CV.• Responsible for Installation clarification and all types of configuration tasks involving 3rd party vendors to the Internal Fujifilm team.• Responsible for providing and maintaining a Synapse OEM Integration matrix available to all Fuji personnel and customers. • Developed, reviewed/approved and implemented IQ, OQ, PQ Protocols and life cycle requirements (Validation Master Plan, UFRS, Risk and Impact Assessment, Data Migration Plan, Test Scripts, RTM, Remediation, etc.) for new and existing equipment/systems within HP Quality Center for validation and managed document workflows in accordance with Quality Assurance Control compliance and regulatory management criteria.• Authored Standard Operating Procedures (SOPs) to ensure compliance with Company policies and federal regulations.