Responsible for planning, directing, and coordinating concurrent global projects across the Quality, Regulatory, Strategic PMO and Global Supply Chain & Logistics functions.

Divisional QA/RA PMO Lead for various programs such as (1) Software as a Medical Device (SaMD) and ISO13485/MDR facility development/registration, (2) Global PMS/Vigilance/Complaint Handling Program (3) Divisional Audit Readiness Program (4) Global Technical Services Intake Hub Optimization program (5) Divisional Quality System Improvements Program.

Head of Quality/Design Assurance at 4TECH Cardio Ireland Ltd. Class III Medical Devices - Transcatheter Tricuspid Valve Repair.

Head of Quality at ArraVasc. Medical Devices Class IIa - Design, development, manufacturing and distribution of Percutaneous Transluminal Angioplasty catheters for peripheral vascular indications.

Global Quality Systems with responsibilities across 14 different manufacturing sites. Lead/SME for ISO13485:2016, MDASP, Site Inspections/audits, QMS Integration, UDI, Supplier Management, CAPA, External Documents Controls, etc.

Responsible for operation in areas such as Drug Eluding Stents, Bare Metal Stent manufacturing, Cutting Balloons, DES Secondary & Final Packaging, PTA Packaging and Business Unit QA Project Lead.

Responsible for Galway site supplier quality function - Regulatory Inspections, Supplier Auditing, Material Qualification, Management Reviews, QMS Optimization/Integration, Issue Resolution/SCARs, Supplier Monitoring & Measuring, etc.

Galway site lead for Risk Based Inspection program. Supplier Quality Engineer for various commodities including APIs, Chemicals, Test Laboratories & Resins. SME/Lead in supplier selection & evaluation, auditing, material qualification, supplier performance and receiving inspection.