Sue Spencer as a currently work for BSI where I have developed an IVD team and set up an IVD Notified Body Serivce. In the past I Worked for Lloyds Register Quality Assurance (LRQA) a UK Notified Body as Technical and Operations Manager managing customer relationships and operational delivery of LRQA Notified Body Services worldwide for the IVD and Medical Devices Directive.
Prior to working for BSI I worked for Abbott firstlyas Manager for International Quality Systems for Abbott Diagnostics supporting 5 International sites in UK, Ireland, Germany, South Africa and Japan to maintain compliance to ISO 13485, implement Division requirements, coordinate cross-site quality system projects and represent the International sites on Division QS projects including validation to CAPA. This included seeing a manufacturing site through ISO 13485 registration on schedule. Also involved in the assessment of International sites for compliance to FDA 21 CFR.
She became Abbott Diagnostices Division Risk Management SME. Developed a risk management process to improve the effectiveness of product development and manage the risk to the user and patient in the on-market phase. Standardised the use of risk management tools approach across the divisions reducing 19 FMEA formats to essentially one design and one process FMEA format.Consulted for 3 years,
Before I Abbott I worked as a consultant and set up Cascade Consulting providing cost effective consultancy service for the IVD and medical device industry. This included the writing and implementing of bespoke quality systems, preparing existing quality systems and technical documentation for CE marking.