David Willard Email & Phone Number

Southampton, England, Gb

Southampton, United Kingdom

Responsible for designing and implementing an ISO 9001 Quality Management System in the university’s Estates & Facilities department.Leading a Quality & Compliance team of four employees.Performance management including appraisals, determination of development needs, and arrangement of coaching and training as necessary.Recruitment and selection of new team members.Mapping processes and promoting continuous improvement initiatives.Measuring, analysing and reporting on quality and compliance across Facilities Management engineering and maintenance activities.Delivering Quality Management training courses.Internal auditing.

Southampton, United Kingdom

Managing the Quality Assurance team and overseeing the product quality of frequent replacement contact lenses at CooperVision's manufacturing facility in Hamble.Leading a Quality Assurance team of seventeen employees.Managing the quality engineering function across two manufacturing sites, including three quality engineers, two quality improvers and two compliance specialists.Responsible for the Process Validation, Risk Management and Engineering Change Management processes across two UK manufacturing sites.Representing Quality Assurance on New Product Introduction (NPI) projects and collaborating with R&D and the European Technical Innovation Group to complete design transfer for new products and processes on to UK manufacturing lines.Responsible for the outgoing quality of packaged, sterile contact lenses from CooperVision's production facility in Hamble.Proactively liaising with other departments to ensure appropriate QA resource, support and input is provided to all operational activities and projects.Maintaining compliance to ISO 13485, ISO 14971, the European Medical Device Regulation, the US Code of Federal Regulations and other international regulations.Taking a leading role during third party audits, including FDA and Notified Body.Trending and reporting KPI’s to the senior management team, including Management Review.Developing and monitoring the departmental budget.Ensuring non-conformances and customer complaints are investigated in a timely manner, and suitable corrective and preventative actions are implemented.

Fareham, United Kingdom

Managing the Quality Assurance team and overseeing the quality of contact lenses and contact lens care solutions at CooperVision's packaging and distribution centre at Fareham.Overall responsibility for the outgoing quality of packaged, labelled, sterile contact lenses from the UK packaging and distribution centre.Managing a Quality Assurance team of twenty employees across three shifts, including the quality engineering function. Hosting third party audits, including FDA and Notified Body.Supplier Management, including supplier auditing, establishing quality agreements, and coordinating non-conformance investigations.Ensuring appropriate QA support and input is provided to all operational activities and projects.Reviewing and approving validation protocols, reports, certificates of analysis and certificates of conformance.Continuous improvement of Quality Assurance processes.

Southampton, United Kingdom

Managing the UK Change Management & Compliance team to ensure all engineering and document changes are controlled to maintain product quality, patient safety and regulatory compliance.Overall responsibility for Change Management, Risk Management and Document Change Control processes across UK manufacturing and distribution, including the European distribution centre in Belgium.Representing the UK QA organisation in global improvement projects for Risk Management and Change Management.Managing the Change Management and Compliance team, including performance management and recruitment.Developing and delivering Risk Management and Change Management training courses.Working with project teams to ensure changes are planned, assessed and accurately documented to ensure effective and timely implementation.Providing quality and regulatory guidance to project teams for all engineering changes.Working closely with project managers to ensure changes are managed in the most effective way, and assigning subject matter experts to participate in risk assessment activities.

Southampton, United Kingdom

Managing the UK Change Management & Compliance team to ensure all engineering and document changes are controlled to maintain product quality, patient safety and regulatory compliance.Overall responsibility for Change Management, Risk Management and Document Change Control processes across UK manufacturing and distribution, including the European distribution centre in Belgium.Representing the UK QA organisation in global improvement projects for Risk Management and Change Management.Managing the Change Management and Compliance team, including performance management and recruitment.Developing and delivering Risk Management and Change Management training courses.Working with project teams to ensure changes are planned, assessed and accurately documented to ensure effective and timely implementation.Providing quality and regulatory guidance to project teams for all engineering changes.Working closely with project managers to ensure changes are managed in the most effective way, and assigning subject matter experts to participate in risk assessment activities.

Southampton, United Kingdom

Providing quality engineering support to to cross-functional project teams for new projects and ongoing contact lens manufacturing processes to ensure regulatory compliance and continuous improvement.Leading risk assessments to ensure appropriate risk control measures are identified and implemented to reduce patient risk as far as possible.Reviewing and approving process validation protocols, risk assessments, document changes, and engineering reports. Ensuring adherence to the design control process during new product/process development.Leading quality audits of suppliers, most notably leading audits in China for two potential suppliers of a critical raw material.

Petersfield, United Kingdom

Managing a small team of quality assurance chemists to provide routine and investigatory HPLC, GC and XRF analysis on cosmetic products.Leading and managing a small team of three chemists.Communicating with operations to prioritise the workload of myself and my team.Creating and maintaining accurate SOPs and Work Instructions.Improving laboratory processes to ensure continual increases in the annual audit scores against FDA regulations for over the counter (OTC) drugs.Representing the QA laboratory during FDA / GMP audits.Analytically testing a large variety of cosmetic products and raw materials for active ingredients, using techniques including HPLC, UPLC, GC, XRF, and NIR.Investigating and documenting non-conformances using root cause analysis.

Southampton, United Kingdom

Member of a largely self-managing laboratory team performing chemical analysis on beverages produced by high-speed, high-volume production lines.Ensuring stringent quality standards are met at every stage of the production process and maintaining compliance to product specifications and legislative requirements.