Supporting the delivery of internal group and external company collaborative contact lens and smart contact lens projects

Provided Quality and Regulatory support in the transfer of the manufacturing process, for the Sensimed Triggerfish continuous ocular monitoring system, from Sensimed to UltraVision. UltraVision successfully became the critical manufacturing supplier for the Triggerfish Sensor and antenna following approval by Notified Body.Provided Quality and Regulatory support in UltraVision's transition from MDD to MDR. Supported the update of the QMS and production of Technical Documentation for the Technical Files. Specific detailed input in terms of Risk Management documentation (BS EN ISO 14971:2019), Biological Evaluation of Medical Devices documentation (BS EN ISO 10993-1:2020) and GSPR's.

• Supported the continued improvement of the QMS • Ensured that the designed products were designed in compliance with BS EN ISO 13485(2016) and other appropriate regulatory standards• Maintained and updated process documentation, document templates and standard checklists. • Managed the CAPA and Non-Conformance processes• Managed the planning, execution and reporting of Internal Audits• Supported surveillance and re-certification BS EN ISO 13485(2016) Notified Body Audits and client supplier audits• Developed the in-house use of Projector Professional Services (PSA) software system to plan, manage and track multi- project delivery• Developed the in-house use of the Matrix Requirements Management software systems to capture and manage product requirements, together with verification testing and reporting • Carried out Design Verification testing on prototype devices• Supported the development and improvement of the transfer to manufacturing process between eg technology, clients and manufacturing partners• Successfully implemented a controlled product assembly area and associated documentation for pre-production prototype client assembly requirements• Supported BS EN ISO 14971(2019) Risk Management documentation requirements for project teams• Supported the development of in-house training materials and implementation of training• Monitored project trends, facilitated project closure down reviews and supported control of project budgets and timescales• Developed and implemented a range of Project performance metrics

Successfully managed the development of a critical care instrument for measuring propofol from a research instrument to an IVD instrument status. CE marking successfully obtained.Managed the production of the launch instruments. Developed close working relationships with key suppliers.Successfully project managed the development and manufacture of a Class 1 Sterile vial solution product for use in a blood gas micro analyser. CE Marking successfully obtained in January 2014. Planned and managed the process validation activities associated with the manufacture of the vial solution product, including terminal sterilisation of final product by autoclaving

Validation of the manufacturing facility. Planned, supported and tracked the progress of the process validation activities. Produced validation documents and protocols. Successfully validated production facilities to IQ, OQ and PQ status for use in the validation of the critical care diagnostic device production facility.

Managed the transfer of professional diagnostic lateral flow products from Unipath to Inverness Medical JapanSuccessfully project managed the transfer of a professional range of lateral flow medical diagnostic products between the UK and Japanese manufacturing sites. Produced project plans using Microsoft Project and facilitated regular review of plans with key stakeholders in both the UK and Japan. Frequent trips carried out to Japan to review project progress and support building design work, equipment installation, training activities, process validation activities, document production and manufacture of product batches.Worked closely with Supply Chain functions to manage the supply of materials to Japan for trial, process validation and launch stock production work. This also included working closely with DEFRA to raise Export Health Certificates for supply of some materials to Japan.Generated Risk Assessments, Validation Master Plans, Process Validation protocols and Validation Summary Reports. Provided technical support during the process transfer process.Delivered the products according to agreed time scales without any disruption to the product supply chains and with improvements to product quality.

Member of Product Transfer Team dedicated to supporting the transfer of new products and processes between R+D and Unipath manufacturing. This role developed into becoming the key manufacturing product transfer support lead for the technology transfer and manufacture of the Clearblue digital pregnancy and Conception Guide products at Inverness Medical Shangai, China. Frequent visits to Inverness Medical Shanghai in China required to ensure a successful manufacturing transfer process.

Main objective was to help implement TPM throughout the whole of Unipath Manufacturing Operations and to help obtain the level one Japanese Institute of Plant Maintenance (JIPM) TPM Excellence Award. This award is seen as the start to achieving world class manufacturing excellence status. To support this programme i was trained to become a TPM Unilver / JIPM accredited instructor. Unipath were awarded the Level 1 JIPM Award in 2002.Led 5S workplace organisation and Focus Improvement Teams. Applied an extensive range of improvement techniques and tools, together with the application of loss / waste analysis.Performed extensive training to employees on TPM principles and implementation

This work was carried out within the manufacturing operations team in the areas of consumer pregnancy, contraceptive and clinical diagnostic device manufacturing. This position involved alot of project and people management work, together with the development of manufacturing links with other companies. A key part of this work was the validation of new products, processes and equipment, together with the management of cost cutting initiatives and implementation of 'Continuous Improvement' initiatives.Managed a team of five people dedicated to product and process improvements within manufacturing. This project work was driven by applying a loss / waste analysis approach and included a lot of cost cutting work. It also included the implementation of Continuous Improvement culture and initiatives and monthly progress report against Key Performance Indicators.

Member of the Research and Development Team engaged in the development, manufacture and technical support of the Persona Contraceptive and Fertility Awareness consumer diagnostic products.Provided on-going technical support for the products together with achieving successful scale up of the manufacturing processes. Developed close supporting links with some critical component supply companies, which included supervising the manufacture of some critical components.

Member of Research and Development and Process Development Teams engaged in the development and manufacture of biosensors, ELISA and LIA immunodiagnostic products. Further experience gained in screen printing and other immunodiagnostic manufacturing technologies, together with experience gained in company technology transfer work.

Member of the Research and Development and Process Development Teams, dedicated to the development and manufacture of the innovative whole blood glucose biosensor,Exactech. Considerable screen printing experience gained during this period with extensive contact with major screen printing companies. Managed the pilot plant production facilities. Exactech was successfully launced in the USA market in 1987.

Performed routine chemical and biochemical analysis of patient samples providing good laboratory based experience. The performing of emergency on-call work meant working accurately under pressure and to tight deadlines.Qualified as State Registered Medical Laboratory Scientific Officer