.Sr. Design Quality Engineer page is loaded Sr. Design Quality Engineer Apply locations PRT - Coimbra time type Full time posted on Posted 3 Days Ago job requisition id R76284 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 Sr. Design Quality Engineer is responsible for implementing, supporting, and sustaining elements of Smith and Nephew's quality system. Under the guidance of the Quality Engineering Manager, they ensures that medical device regulations, standards, and guidelines are aligned with through execution of Smith and Nephew procedures.What will you be doing?Provide quality support for manufacturing and product development processes and personnel to assure compliance with DOPs and GMP requirements. Pursues resolution of issues and problems as they arise.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.Provide coaching and training for junior members of the quality team.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: Provide quality leadership 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 manufacturing operations and guide in product requirements, risk management, test methods, and statistical analysis.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.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
