Ireland
Senior Vice President QA RA at Mammotome, a Division of Devicor Medical Products, Inc.
Medical Devices
Education
Irish Management Institute 2008 — 2009
Diploma Executive Coaching, Coaching, Leadership, Psychometrics
The Royal College of Surgeons 2003 — 2005
Masters in Industrial Pharmaceutical Science (QP), Biochemistry, Process and Production, Pharmaceutics, Chemistry
Trinity College Dublin 1981 — 1985
Microbiology, Biochemistry, Genetics, Physics, Maths
Experience
Devicor Medical Products, Inc. January 2014 - Present
Devicor Medical Products October 2010 - January 2014
Boston Scientific April 2010 - October 2010
Boston Scientific January 2007 - March 2010
Hospira December 2004 - December 2006
Hospira October 2001 - December 2005
Abbott Laboratories December 1993 - September 2001
Skills
Medical Device Directive, Change Control, ISO, FDA GMP, CE marking, Design of Experiments, ISO 14971, CQA, Sterilization, Aseptic Processing, ISO 13485, Leadership, 21 CFR, DMAIC, Regulatory Affairs, GxP, Quality Assurance, Design Control, FDA, Root Cause Analysis, Quality Management, Validation, V&V, Minitab, Medical Devices, Continuous Improvement, Quality Auditing, Supplier Quality, Pharmaceutical Industry, Manufacturing, Lean Manufacturing, Product Launch, Six Sigma, Quality System, 21 CFR Part 11, GMP, SPC, Auditing, Cross-functional Team..., CQE, CAPA, FMEA, Computer System...