Gavin Williams

WORK HISTORY

EDUCATION

SKILLS

ABOUT GAVIN WILLIAMS

The areas which I have worked in has provided me with knowledge of Quality Systems within the Medical Device and Automotive sectors. I have been part of teams which have implemented, developed and maintained systems to achieve the following accreditations; ISO9001, ISO13485, Medical Devices Directive 93/42/EEC inc. 2007/47/EC, TS16949 and compliance. I have over 12 years experience in this area and within this time, I have worked for two start-up medical device companies as well as, established automotive companies.98/79/EC - In Vitro Diagnostics Directive Good understanding of cleanroom manufacturing to ISO07/08, with added experience of sterilisation processes and validation, including Gamma and Steam.I managed a complete product transfer of medical devices from a manufacturing facilities in central Asia back to the UK at a reduce cost and improved product quality. This product transfer also created jobs within the West Wales area.Experience in maintaining, creating and submitting RG2 forms, technical files and Class design dossiers. I set up a program which would reduce the number of technical files from 28 to 6.As Development Manager in charge of a New Product Development team of eight, I have helped develop and introduce 70+ product lines including working with surgeons on new ideas which includes taking their idea to market. Contract Management also fell under my remit as Development Manager. Within my last two positions I have provided potential cost savings in excess of 360K and within a year period at my previous company, I became a key figurehead in the product validation and testing program of a technologically ground breaking Insulin Pump.Specialties: Project Management, New Product Development, Quality Systems, Good People Skills, Problem Solving, Cost Saving Ideas, VA/VE, Kaizen, Lean Manufacturing, Good Common Sense Business Approach, Marketing.