Ireland
VP, QA & RA, International at Teleflex Medical
Medical Devices
Experience
Teleflex Medical January 2013 - Present
Boston Scientific April 1996 - December 2012
Inamed 1993 - 1996
Skills
R&D, 21 CFR Part 11, Change Control, Root Cause Analysis, Post Market Surveillance, Catheters, GAMP, Design Control, Quality System, V&V, FDA GMP, DMAIC, Medical Devices, ISO, CQE, Quality Management, Management Review, Computer System..., CE marking, Biomedical Engineering, Design of Experiments, IEC 60601, Validation, Process Simulation, Six Sigma, FMEA, Minitab, Regulatory Affairs, CAPA, Sop, Technology Transfer, CQA, Quality Systems Design, ISO 13485, Quality Auditing, Biocompatibility, Iso 9000, Regulatory Requirements, ISO 14971, Medical Device Directive, FDA, PMA, Supplier Quality, 21 CFR, Quality Assurance, GMP, SPC, Regulatory Submissions, GLP, Quality Control