APS Materials is a bio-medical service provider to the Orthopaedic marketplace. With its headquarters in Dayton, Ohio, USA, it provides both porous and bio-active thermal coating systems to the worlds leading Orthopaedic OEMs.APS Materials Ireland was established in Waterford in late 2005 and as a key member of the business start up team, I have developed and successfully implemented a number of key projects.- Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls.- Technology transfer of new process & product start up from APS USA to APS Ireland. - Validation Projects Manager including validation of equipment, processes and expanding product range.- Regulatory Affairs representative including management of the FDA Master File programme and various customer related 510k and PMA projects.- Management of new product introduction and validation into established production systems. - Development, implementation and day to day operation of the ISO13485:2003.QMS standard.- Supplier Performance Management with responsibility for suppler selection and evaluation including the auditing of suppliers in both Europe and the USA.- Coordination of the APS internal audit programme and external second/third party audits.- Continual Improvement initiatives resulting in the introduction of key process developments and cost reduction initiatives.- Preparation and communication of quality performance KPI’s and metrics for input at both senior management and corporate levels.- Customer Interface Management to ensure quality requirements are consistently achieved and understood.- Performance Appraisal and employee evaluation of all quality personnel.- New business development as a member of the APS Materials delegation at various Orthopaedic trade events.