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. This role will implement, support, and sustain elements of Smith & Nephew's Quality System through procedure generation, training, auditing, and technical support. The Quality Engineer determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for ISO, EN, MDR, and QSR requirements. What will you be doing? 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 provide expertise in product requirements, risk management, test methods, and statistical analysis.Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD/EU MDR requirements.Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.Work with outside labs and suppliers to communicate Smith & Nephew product/process requirements as well as assess capabilities of the outside lab/supplier.Support continuous improvement activities (CCRs and/or PARs).Support Post Market Surveillance activities, Management Review, and audits/inspections. What will you need to be successful? Education: Bachelor's degree in engineering or related discipline. Experience: No experience required - Some medical device or related regulated industry or internship will be valuable. Fluent spoken and written in English. Competences: Need to be able to make sound decisions with attention to details.Understanding the impact of regulatory requirements (eg. GMP's, ISO 13485, ISO 14971, and MDR) on Smith & Nephew's products is necessary.Must be able to provide and implement solutions to quality problems.Ability to plan and schedule multiple projects and tasks.Team player.MS Office, MS Excel, and Statistical software proficiency. You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Applications: If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you. We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients. We value the diversity of our people and welcome applications from everyone.
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