Dave Walters Email & Phone Number

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

Leighton Buzzard

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.

Cambridge, United Kingdom

• 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

Cambridge, United Kingdom

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.

Cambridge, United Kingdom

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.

Bedford, UK

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.

Bedford, UK

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.

Bedford, UK

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 /.

Bedford, UK

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.

Bedford, UK

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.

Ely, Cambs

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.

Abingdon, Oxon

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.

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

Honours 2:2, Biochemistry

Education record