Supplier Quality Engineer

JOB PURPOSE (ROLE DEFINITION): The Supplier Quality Engineer will support the Group Supplier Quality Assurance Team Lead with the quality compliance culture within the Group ensuring all staff are aware of the Companies’ Business Management System and the need to adhere to it. Responsible for the management of supplier materials, working with suppliers to identify root causes and implement effective countermeasures in line with procedures, ISO 13485, Medical Device Single Audit Program (MDSAP), and Medical Device Regulation (MDR). Undertake a proactive approach with both internal stakeholders and suppliers to reduce the overall cost of poor quality. Responsible for the supplier performance and management program. Assist with the management of supplier Non-Conformances (including root cause investigations and CAPA). Consult with suppliers on quality issues from failures. Lead desktop or on-site supplier audits – ISO13485:2016 and ISO9001:2015. Provide assistance during improvement activities. MAIN DUTIES AND RESPONSIBILITIES Ensure 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). Support the promotion of supplier quality awareness of applicable quality requirements and Business Management System requirements throughout the Group. Assist with the planning, scheduling, and conducting internal audits and supplier audits. Ensure compliance with 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 Business Management System and quality documentation throughout the Group. Manage, with input from other business functions, the supplier selection, approval, and ongoing Supplier evaluation process. Support internal projects by providing guidance on supplier evaluation. Manage supplier concessions and 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. Input to Supplier Quality performance for Management Review and other Top Management reviews. Participate in the CAPA process. Travel to suppliers to perform supplier audits. MANAGEMENT RESPONSIBILITIES N/A

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