Systems Auditor/Quality Assurance Engineer
Johnson & Johnson Orthopaedics Europe
New Milton Hampshire (Design And Manufacturing Engineers Of Orthopaedic Implants
Managed the audit schedule and resource in a ‘Worldwide Centre of Excellence’ facility, carried out quality audits on and off site in line within the requirements of ISO 9001, the BSI, GMP and the FDA. Reviewed system, documentation, working methods and procedures and provided written reports for areas of improvement.Controlled and produced monthly/quarterly non-conformance reports and reviews for European/Worldwide reporting.Prepared Manufacturing and Quality Specifications, Standard Operating Procedures, Engineering Change Requests and Deviation requests for computerised ‘Documentum Control’Supervised the ‘Operator Inspection’ training and authorisation program.Liased with R&D, QA and Engineering Manufacturing to carry out inspection using a variety of measuring equipment, including both manual and CNC CMMs.Participated in FMEA meetings.Produced Protocols and carried out validation of CNC CMM programs.Supervised the quality function, of the retrospective CE marking exercise at the European Distribution Warehouse, for an associated medical device company. I was also the QA representative on an action group that introduced new product return and complaint procedures for European affiliates and sat on a Material Review Board.Provided operational support for the Controlled Area clean room, Goods Inwards, and Calibration department.Assisted, on/off site, with the production transfer to new facilities in Ireland and Leeds. Carried out validation of the CNC CMM programs and also provided support for other quality functions at the New Milton plant, including microbiology monitoring and calibration records during this period. 1998 - Bywater, ‘Internal Quality System Auditor’1999 - Bywater, ‘IRCA Lead Auditor’ Course and examination1999 - Institute of Quality Assurance, A11 Course passed with Credit