16 years management experience in a FDA cGMP and ISO 13485 Quality Systems, in a medical device manufacturing environment Management of a Quality Control staff, in a machine shop fabrication and final product approval, MRB, Engineering new product approval to Internal and ISO external test requirementsInternal and external complaint resolutionISO 13485 certified lead auditorDomestic and international Regulatory affairs experience, CE mark technical file requirements FDA 510k preparation and submissionsDevelope, update and implement SOP's and WI's to meet FDA and ISO 13485 requirements

Management of FDA cGMP Quality System, a Class 1 medical device manufacturer Manage Quality Control staff, internal machine shop fabrication and final product approval, MRB and internal and external complaint resolution. Internal and external test requirements.ISO 13485 certified lead auditorRegulatory affairs domestic and international, CE mark technical file requirements FDA 510k preparation and submissionsMember of three ANSI/RESNA & ISO Wheelchair standards committees as a participating expert.Safety ManagerMaintain company compliance to federal & state OSHA and local fire and facility requirements

Designed and manufactured automated inspection equipment for the bottling industry.ISO 9000Calibration TechnicianSource InspectorQC InspectorInternal ISO auditor

Fairchild Corp.Fairchild Controls Manhattan Beach CA.Inspection Supervisor Machine shop operationsQC Inspector Source InspectorMilitary Air Force, FAA and NASA requirements