.Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This position will be based in Coimbra (Hybrid role) and will be reporting to Design and Quality Engineering Manager. The Design Quality Engineer is responsible for implementing, supporting, and sustaining elements of Smith and Nephew's quality system. Under the guidance and direction of the Quality Engineering Manager, they ensure that medical device regulations, standards, and guidelines are aligned through the execution of Smith and Nephew procedures. What will you be doing? Analyze post market surveillance data, identify trends and verify products are performing within established risk profiles. Prepares and presents results of analysis to Sports Medicine leadership in Post Market Surveillance Trend Review meetings. Perform routine updates of product risk management files per Smith and Nephew procedures. Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions (e.G. product quality, product transfers, complaints, labeling, validation, automation of systems, etc.). Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products. Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures. Establish and maintain successful multi-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments. Coordinate corrective actions for issuance, review and closure of action plans. Responsibilities: Generate/approve/manage post market surveillance and risk management activities. Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and EU MDR requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System. Provide quality oversight and leadership for quality related issues (e.G. non-conforming material, corrections, deviations, CAPA, etc.). Investigates, documents and leads corrective/preventive actions to assure these are managed effectively. Provide quality support to product support project teams as the quality engineering representative. Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation. Support Management Review, and internal and external audits/inspections. Assist in other responsibilities requested by management to ensure compliance
