Ed Smith Email & Phone Number

Oxford, England, United Kingdom

Witney, Oxfordshire, Uk

Lead and Manage the UK Supplier QA Team to deliver the following: - Planning and execution of the UK Supplier audit schedule- Developing and maintaining supplier qualification plans.- Diligent and Compliant execution of the Supplier Change Management and Performance Monitoring programs- Compliant metric program deployment & management - Establish and maintain relationships with key stakeholders at local, divisional and corporate levels to deliver aligned supplier management strategy- Effective financial performance and conductance of activity in line with department budget confinementAccountable for all activities described within previous role of Supplier Quality Engineer

Witney, Oxfordshire, Uk

- Perform the selection, qualification and approval of suppliers during the development of new/changed materials- Plan, perform and manage audits at supplier sites, including all follow-up activities- Work with suppliers to ensure supply quality issues are addressed effectively and maintain the approved status for all suppliers of the functional area.- Develop supplier quality systems in line with Abbott Diabetes Care’s quality requirements.- Review and track supplier performance, taking appropriate action when required- Assess and approve supplier change requests- Ensure that procedure and practice implemented within supplier quality are consistent with best practice and comply with the necessary Quality and Regulatory requirements- Maintain area audit readiness for internal and external Quality System audits - Generate Supplier QA metrics to meet division and site management review requirements- Train others on supplier QA procedure and audit techniques- Identify and implement improvements in both internal and supplier processes

Witney, Oxfordshire, Uk

- Ensure quality/compliance issues are identified with timely decisions to facilitate internal customer product supply- Participate in and support the progress of failure/quality/customer complaint investigations and CAPAs assigned to the process area- Review and approve document change requests from all areas for the Quality and Compliance department- Review and approve Non-conformance Reports as a member of the Quality Review Board- Support and provide quality/compliance/GMP education deployment- Participate in and support the Quality and Compliance elements of Business Excellence projects; identify and implement quality system and manufacturing process improvements - All responsibilities as listed with previous position of Quality Support Specialist

Witney, Oxfordshire, Uk

- Responsible for the management of ~30 Manufacturing Operators- Accountable for the manufacture of finished products to meet production targets in accordance with agreed schedules

Abingdon, Oxfordshire, Uk

- Responsible for maintaining the effectiveness of the Quality System at the site in accordance with divisional requirements and applicable regulations: - Code of Federal Regulations 21 CFR part 820 - GMP for Medical Devices - ISO 9001 - ISO 13485 (Medical Devices)- Monitor and ensure compliance with Good Manufacturing Practice (GMP).- Make quality decisions on product during product processing and manufacturing. Ensuring quality and production requirements are considered without detriment to either.- Lead and assist in projects to enhance and further assure the quality system and product.- GMP auditing of the production facility.