Supplier Quality Assurance Team Lead

Job Purpose (Role Definition):The Supplier Quality Assurance Team Leadwill manage and provide leadership to the Supplier Quality Assurance Team;is responsible for developing, implementing, maintaining and supporting the Manufacturing and Supplier Quality Manager on the promotion of the Quality Assurance strategy;is responsible for supporting the Manufacturing and Supplier Quality Manager with the quality compliance culture within the Group ensuring that all staff are aware of the Companies’ Business Management System and the need to adhere to it.The position alsoincludes maintaining the Companies Quality Management System and ensuring compliance to all applicable regulations and standards;has responsibility for ensuring compliance with ISO 13485, Medical Device Single Audit Program (MDSAP), and other regulations under which the Companies sell their products;has responsibility for keeping abreast of changes to ISO 13485 and MDSAP regulations impacting on the business. This position is also responsible in keeping the Manufacturing and Supplier Quality Manager and other key stakeholders up to date with such regulatory changes;supports the Manufacturing and Supplier Quality Manager with Continued Improvement activities and initiatives across the Companies using best practices such as Lean Six Sigma and Lean Manufacturing.Main Duties and ResponsibilitiesEnsure that supplier quality processes needed for the Business Management System within the Group are documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR);Report to Manufacturing and Supplier Quality Manager on the effectiveness of the supplier quality processes within the Business Management System and any needs for improvement;Support the promotion of supplier quality awareness of applicable quality requirements and Business Management System requirements throughout the Group;Is responsible to reporting to the Manufacturing and Supplier Quality Manager on the supplier quality performance of the Quality Management System.Is responsible for the planning and preparation of supplier audits.Ensure compliance to all applicable supplier quality standards, regulations and internal procedures by proactively interpreting Quality requirements, and devising and implementing solutions to support the maintenance and enhancement of the Quality Management System and quality documentation throughout the Group;Manage with input from other business functions, supplier selection, approval and ongoing Supplier evaluation process. Support internal projects by providing guidance on supplier evaluation and other supplier related activities.Is responsible for the Management of supplier concessions and Supplier Corrective Action Report (SCARs);Periodic review of supplier certification and documentation;Manage, with input from other key stakeholders and work streams, the Supplier Quality performance Score Card analysis;Provide input to Supplier Quality performance for Management Review and other Top Management reviews;Participate in the CAPA process;Support the Manufacturing and Supplier Quality Manager with the preparation of the Group Quality Management Reviews;Travel to all Manufacturing Group sites is required in order to maintain visibility and support the Manufacturing and Supplier Quality Manager with the visibility and compliance of Quality Assurance needed for the Group;Travel to suppliers to perform supplier audits.Management ResponsibilitiesSupplier Quality Assurance team.
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