Ireland
Experienced Medical Devices Professional
Medical Devices
Education
National University of Ireland, Galway 1984 — 1989
BSc, HDIP in Ed, Dip in QA, Physics, Education, Quality Assurance
Experience
EKF Diagnostics July 2013 - Present
SMART MTS, Quality, Regulatory and Commercialisation Consultancy for Medical Technology Companies June 2010 - Present
Abbott March 2012 - March 2013
Dublin City University January 2009 - April 2012
Trinity Biotech October 2005 - January 2009
Trinity Biotech April 2004 - October 2005
Biomedical Research Ltd. 2001 - 2004
Boston Scientific 1996 - February 2001
Baxter Healthcare 1989 - 1996
Skills
Manufacturing, Design for Manufacturing, CAPA, Process Improvement, Mergers, Mergers & Acquisitions, Supply Chain, Testing, Continuous Improvement, Quality Assurance, Biotechnology, Product Development, Lean Manufacturing, Pharmaceutical Industry, Medical Devices, Product Launch, SPC, Lifesciences, V&V, Design Control, Molecular Biology, R&D, Minitab, GMP, Quality System, FDA, Regulatory Affairs, Design of Experiments, Technology Transfer, DMAIC, Regulatory Requirements, Biomedical Engineering, Hardware Diagnostics, Root Cause Analysis, Business Process, Integration, Chemistry, Validation, ISO 13485, Operations Management, Marketing, Quality Management, FMEA, GLP, ISO 14971, 21 CFR Part 11, Six Sigma, Biopharmaceuticals, Sop, Commercialization