Lorcan McMahon

Device Quality Engineer for legacy combination products and Medical Devices. Responsibilities Included • Design Quality review of legacy combination product design records • Compilation and maintenance of Design History Files for combination products • Creation of full Risk Management Files to requirements ISO 14971 for legacy combination products • Supplier/Vendor Quality Management as needed

Responsibilities included: - Design Quality representative on project Core team for launch of new IVD laboratory automation system. - Compilation of technical files for CE marking - Co-ordination of risk management activities - Risk Assessments - Quality aspects of dFMEA and pFMEA - Quality review of all technicial documentation and design records - Quality rep on Design Change team for existing product range

Short term contract to compile a gap analysis of client QMS and associated records against the requirements of 21CFR in anticipation of a potential FDA QSIT audit. Project was aimed at highlighting of areas of concern and raising required CAPAS. Clients identity withheld.

Review of all technical documentation for regulatory compliance, creation and maintenance of Technical Files / 510(k) / STED for regulatory approval and clearance.

Compilation of Regulatory Submissions to National Competent Authorities including pre-market clearance/license applications such as 510(k) Pre-market Notification to the FDA. Review of national and international regulatory laws, directives, testing standards etc. to ensure compliance. Risk Management Supplier Audit and approval. CAPA