Nicholas John

WORK HISTORY

SKILLS

ABOUT NICHOLAS JOHN

Did you know that; fish that live more than 800 meters below the ocean surface don\'t have eyes?As a Quality Manager your eyes are one of your most vital tools in assessing the world around you, be that Auditing of the supply chain, Analysis of defects, Proofing IFU’s or just keeping abreast of regulatory requirements and spotting the not so obvious changes.This stems from my love of fine art and being a budding boarding on failed artist my keen eye for details is now predominantly used for work rather than pleasure.Having worked in the field of Quality for over 20 years with over 12 years within the medical device industry. I have gained in-depth knowledge of materials engineering and of product and process validation. Also gaining in-depth knowledge of implementing and improving Quality Management systems compliant to ISO 9001 and 13485, developing the systems to ICH Q9 (Quality Risk Management). Working to such standards as;ISO Annex SLISO 9001 ISO13485ICH Q9ISO19011ISO14•••93/42/EEC98/79/EC MEDDEV’s including Clinical Evaluation, Clinical Investigation and Post Market Surveillance Labour Standards Assurance SystemsSA (SMETER)By Now your attention span is dwindling….Did you know the average attention span measured by statistic brain was 8 seconds in 2013 and 12 seconds in Does this say something about us? The average attention Span of a gold fish is 9 seconds…. Moving along quickly!I am an MHRA Responsible Person; RP Number 78•••82 for the Williams Medical Wholesale Dealers Authorisation, sale and transportation of pharmaceutical product to the UK market and to ensure that the company remains complaint to the cGDP.I have successfully developed the companies current systems to be compliant with the NHS Supply Chain LSAS, developing our supply chain and aligning our suppliers with The ETI Base Code, SEDEX/SMETER,