ABOUT US
Steve Moody, principal consultant at Steven M Moody & Associates, started his technical career in UK working at the General Electric Company’s Hirst Research Centre in Wembley, Middlesex, while at the same time studying engineering, computer science and electronics in London (UCL). The Hirst Research Centre was a leader in the development of global defence and aerospace technology. The Centre was involved in the secretive development of radar and weapons guidance systems, telecommunication technology, lasers, semiconductors and large scale integrated circuit design.
After graduation in 1969, Steve moved to Australia and joined Amalgamated Wireless Australia. The Company was the largest and most prominent electronics organisation in Australia at the time and like GEC was also involved in defence and aerospace technology development.
At AWA Steve joined the microelectronics division (AWM) and worked in process development before supervising production. He also became a member of the Australian Organisation for Quality and was trained in ISO 1001 Quality Management Systems then set up and managed AWM quality assurance. During his tenure at AWA, Steve contributed to the development of defence and medical device projects including antisubmarine systems and the microelectronics for implantable pacemakers.
It was through his work at AWA with implantable pacemaker components Steve was recruited by the parent organization of the pacemaker manufacturer Telectronics and bionic ear manufacturer Cochlear the Nucleus Group to be the Quality Assurance Executive of Ausonics, a new subsidiary set up to develop and manufacture medical diagnostic ultrasound equipment. Steve established the Quality Management System of Ausonics and obtained regulatory clearance to market ultrasound equipment in Australia, New Zealand, USA and Europe.
When the need arose to manufacture a new pacemaker programmer for Telectronics, Steve was appointed Business Unit Manager of the Instruments Division. After a successful tenure in that role and external training in value and concurrent engineering, Steve was promoted Manufacturing Engineering Manager of Telectronics Pacing Systems, manufacturing implantable pacemakers and cardioverter defibrillators. Steve was responsible for new product process introduction (NPI) production engineering (PE), process qualification (IQ/OQ/PQ) the drafting office, workshop, equipment maintenance and calibration and product sterilisation.
During his 7 year tenure at Telectronics Steve benefited from an extensive range of company sponsored external training courses including risk management, Failure Modes & Effects Analysis, Quality Function Deployment, Validation Methodology, Microsoft Software Project Management, Statistical Process Control, clean room design, product sterilization and current Good Manufacturing Practice.
When Telectronics was acquired by St Jude Medical USA in 1996, Steve left the Company and set up
Steven M Moody & Associates, the first contract being the provision of engineering support to the Australian Nuclear Science and Technology Organisation (ANSTO) at Lucas Heights near Sydney. He and his associates worked on the development of the SYNROC radioactive waste management system used in Australia, the US and the EU.
Overlapping and beyond the ANSTO project, Steve undertook consulting projects in the US including work on weapon guidance systems, aerospace equipment and medical devices. He became a member of the American Society of Quality, Biomedical and Audit Divisions, underwent training and certification in; Auditing ISO13485 Medical Quality Management Systems; the US FDA Current Good Manufacturing Practice 21 CFR Parts 820 Quality System Regulation; the FDA approval process to market medical devices in the US; the European Medical Device Directive and Conformity Assessment Procedures for the EU and CE Marking. Steve also received training by the FDA in Quality System Inspection Techniques (QSIT) provided to FDA Field Investigators and attended regulatory affairs workshops by the US Justice Department.
TEXCEL Incorporated was one of the companies in the US that Steve assisted with ISO13485 certification. In 1997 Steve was offered the full time position of Director of Quality Assurance of Texcel in Massachusetts. He and his wife moved there while two of his associates continued his consulting practice on projects in in Australia. At the time, Texcel in the US was a leader in controlled atmosphere laser processing, assembly and hermetic encapsulation of aerospace and defence electronics, assembling medical devices and telecommunications components. Everything from processing parts for jet engines and other aircraft assemblies, to implantable neural stimulators, pacemakers, cardioverter defibrillators, ventricular assist devices, spinal implants and endoscopic surgical instruments as well as fibre optic couplers.
As part of upgrading Texcel’s Quality Management System to meet latest aerospace, medical and defence standards, Steve introduced Made2Manage ERP Software to the company to manage all their business operations, from quote to cash including, parts bar coding, product lot and quality control. As part of this initiative, Steve and a representative from each department received certified training in the customisation, implementation and operation of the M2M ERP System. In addition to managing quality assurance at Texcel and the ERP system, Steve assisted with process development, managed the design and construction of the facility class 10,000 clean room and introduced Self Managed Action Response Teams. SMART teams increased productivity of the Company’s high volume aircraft parts and surgical instrument production lines.
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