Ireland
Risk Management, Quality Systems, Audit preparation, ISO, FDA, MDD compliance.
Medical Devices
Education
University College Cork 2001 — 2003
Higher Diploma Health Safety Welfare at work, Risk Management
Dublin City University 1991 — 1995
BSc Biotechnology, Environmental Science
Experience
Independent Quality Consultant January 2009 - Present
Trinity Biotech January 2005 - January 2009
Stryker Orthopaedics September 2003 - January 2005
Stryker Orthopaedics September 2000 - September 2003
Boston Scientific September 1997 - September 2000
Vistakon April 1996 - September 1997
Skills
Technology Transfer, Process Improvement, R&D, Regulatory Submissions, Quality Assurance, FDA, ISO 13485, DMAIC, CAPA, Cross-functional Team..., Documentation, Laboratory, Design of Experiments, Manufacturing, Quality Management, Supplier Quality, GxP, Cleaning Validation, Biotechnology, Iso 9000, Validation, Lifesciences, GMP, Root Cause Analysis, Six Sigma, Microbiology, FDA GMP, Medical Device Directive, Continuous Improvement, ISO 14971, Process Validation, Design Control, QSR, Process Engineering, Lean Manufacturing, Auditing, Compliance, Life Sciences, Product Development, Sop, Software Documentation, Problem Solving, Change Control, Quality Systems, 5S, Medical Devices, FMEA, Regulatory Affairs, ISO, Quality Auditing