Main purpose of the role

To improve the quality reliability of the supplier base. Ensure supply quality issues are addressed effectively and maintain the approved status for all suppliers of the functional area. Perform the selection, qualification and approval of suppliers during the development of new/changed materials. Ensure that procedure and practice implemented within supplier quality are consistent with best practice and comply with the necessary Quality and Regulatory requirements. To support the creation and development of an environment in which Health and Safety is an individual and collective responsibility. To be an effective member of multifunctional teams. Ensure that all communications, interpersonal interactions and business behaviours are consistent with a Centre of Excellence and the Abbott Code of Conduct. Maintain awareness of area financial performance and support the development of cost efficient business processes whilst ensuring compliance and quality requirements are met.

Main Responsibilities

• Maintain the approved status for all suppliers of the functional area. Plan and perform audits at supplier sites, follow through all audit related corrective actions to completion.

• Select suppliers on their demonstrated ability to meet the company specified quality requirements. Develop and maintain the supplier Quality System assessment schedules. These include schedules for onsite audits and postal questionnaires.

• Review and track supplier performance, contacting suppliers to discuss / resolve any adverse trends / issues identified. Approve Quality System records and documentation associated with Suppliers including change requests, the approved supplier list, technical agreements, specifications and procedures.

• Develop and maintain supplier qualification plans for material introductions, associated with second source programme and new products. Ensure that local quality and compliance requirements are considered when introducing suppliers or when handling supplier related changes.

• Work as an integral member of design transfer teams. Work with suppliers to develop their quality systems in line with the company’s Cares quality requirements. Work with suppliers to resolve supply quality issues. Responsible for agreeing the appropriateness of all associated CAPA plans.

• Update and maintain Supplier Quality Assurance procedures to ensure on-going compliance with all quality system, regulatory and the company requirements. Ensure that procedures and practice comply with the necessary Quality and Regulatory requirements.

• Ensure the area audit readiness for internal and external Quality System audits. Maintain the effectiveness of the Quality System at the site in accordance with Abbott requirements and applicable regulations.

• Generate Supplier QA metrics to meet division and site management review requirements. Ensure that Environmental Health and Safety (EHS) requirements are satisfied at all times. Ensure a safe working environment.

• Train others on supplier QA procedure and audit techniques. Responsible for the quality interface with suppliers and service providers. Support a work environment that ensures team effectiveness.

• Demonstrate full cross functional/ matrixed team support for the Manufacturing Area.

• Participate in and support Business Excellence projects that impact the area. Identify and implement quality system related improvements.

• Ensure effective communication within the process area and support the attainment of the company’s quality goals and business objectives. Work within the local area to ensure responsible fiscal management.

• Must be willing to travel (including outside the UK) and some overnight business trips will be required.

Qualifications

• Bachelor’s degree in Engineering or Science (Master’s preferred).

• 4–8 years of experience in component quality or manufacturing.

• Strong knowledge of validation, DFM, and supplier quality systems.

• Proficient in statistical analysis and quality tools.