Greater Cardiff Area
My responsibilities include carrying out FDA remediation work, all aspects of implementation of ISO 13485 systems, Internal auditing, Supplier auditing, metallurgical failure investigations of medical devices, risk management reviews to ISO14971, Technical file compilation, 510(k) submissions, Health Canada submissions, introducing software validation processes, hosting many regulatory audits, re-classification audits, I have worked at several companies in a consultancy role. These organisations include a dental company, insulin drug delivery medical electronics company, the leading manufacturer of implantable PEEK material, a leading UK customs orthopaedic implant company and an innovative medical device start-up company.
IRole entails managing the quality function of a small dynamic electronic medical device company. The responsibilities range from FDA 510(k) approvals to ISO9001 / 13485 system compliance and to managing quality at subcontract manufacturing in China and responsible for quality aspects of production transfer from China back to the UK. Developed good working knowledge of ISO14971, EN60601, ISO 62304 and IEC 62366.
Managed all QA functions across two UK manufacturing sites. Responsible for implementing and maintaining an improved complaints / vigilance system, implemented CAPA system, hosted regulatory audits (BSI and FDA), improved shop floor quality levels, implemented supplier control processes, significant input into RFQ process for castings and forging resulting in several million pounds cost reduction. Responsible for a department of 70 personnel including quality engineers, calibration, shop floor inspection, supplier control and new product development.