Quality professional with > 20 years experience in Medical Device / In Vitro Diagnostic Devices, manufacturing in high volume, highly regulated cGMP environments to supply to World wide markets. Application of the requirements of Regulations most specifically ISO 13485:2003, ISO9001:2008, 21 CFR 820 and 200 series, 21 CFR part 11, MDD93/42/EEC, IVDD98/79/EC, PS9000 and 9100 series, CMDR, SOR/98-282, rPAL for Japan, ANVISA and applicable harmonised standards and guidelines. Experienced Lead Auditor on a global scale assessing compliance to the above requirements. Able to provide sound Leadership to foster an environment of continuous Business improvement and accountability. Experience of strategy development, deployment and oversight in a project driven manner, to ensure achievement of Company goals and objectives within budget and time restrictions.

Senior Q&R Compliance Auditor @ From December 2011 to Present (4 years 1 month) Quality Systems Development Manager @ From May 2003 to December 2011 (8 years 8 months) Quality Assurance @ From December 2000 to May 2003 (2 years 6 months) Quality Assurance @ From June 1995 to December 2000 (5 years 7 months)

BSc hons, Biochemistry @ University of Strathclyde From 1990 to 1994 School name: Alexis Williams is skilled in: ISO 13485, GMP, FDA, Quality Control, Quality Management, Change Control, Quality System, Medical Devices, Root Cause Analysis, Manufacturing, Quality Assurance, Continuous Improvement, CAPA, Six Sigma, ISO