+20 years Medical Device and Pharmaceutical experience.Orthopaedic Implants and delivery systems, Implantable Cochlear devices, Cardiovascular Stents (Drug Eluting) and MD & Pharma Packaging. Information Security Management System (ISO27001) implementer and lead.

- Software Quality Engineer (CSV SME)- IT Project Manager- Process Development EngineerComputer System Validation Subject Matter Expert for Manufacturing, IT and Design & Development of Medical Device manufacturing and Medical Device SoftwareTrained Internal, External and Software Service Provider AuditorProcess Development Engineer for Spray Coating of Drug Eluting Cardiovascular StentsProject Manager for IT Systems Validation, Implementation and RolloutFDA, TUV, TGA and MDSAP audit experienceContinuous improvement activities for Quality Management System Member of purchasing review team for software service providers

MEDICAL DEVICE SOFTWAREDevice Firmware/SoftwareProgramming SoftwareRemote Software DevicesMobile ApplicationsMedical Device Data SystemsMEDICAL DEVICE MANUFACTURINGAutomated Systems Validation -Pharmaceutical-Non-PharmaceuticalOff the ShelfCOTSBespoke (in-house developed) software for PharmaceuticalIT Software ValidationComplaints Handling SystemsDocumentation Management SystemsERP (Oracle and SAP)CRM (Salesforce)Cloud Computing (AWS)Cybersecurity (Medical Device, Mobile Applications and IT infrastructure)Waterfall and Agile Software Development Life-cyclesGAMPTIRAAMI QSR CertifiedREGULATIONS, STANDARDS & GUIDELINES21 CFR Part 820 21 CFR Part 11EN ISO 13485IEC 62304ISO 14971ISO 27001IEC/TR 80001-2IEC/TR 80002-1ISO 15408AAMI TIR45, TIR57, TIR32 and TIR36Annex 11: Computerised SystemsMDDS FDA GuidanceNIST Framework, 800-53 & 800-66FDA Pre and Post Market Cybersecurity GuidanceExperience includes:JIRA, Confluence, JAMA Contour, HPQC, Windchill (PDM), Risk Management, Pharmaceutical cGMP, Anatomy and Physiology of the Cardiovascular System, Opentext, SAP, Oracle, Trackwise, MiniTab, Vartran & StatEase (Green Belt Trained)