Sr. Design Quality Engineer

<p>Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.</p><p></p><p>This position will be based in Coimbra (Hybrid role) and will be reporting to Design and Quality Engineering Manager. </p><p></p><p>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.</p><p></p><p>What will you be doing?</p><ul><li>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.</li><li>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.).</li><li>Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products.</li><li>Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures.</li><li>Provide coaching and training for junior members of the quality team.</li><li>Establish and maintain successful multi-functional relations with Materials, R&amp;D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments. Coordinate corrective actions for issuance, review and closure of action plans.</li></ul><p></p><p>Responsibilities:  </p><ul><li>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. </li><li>Support manufacturing operations and guide in product requirements, risk management, test methods, and statistical analysis.</li><li>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.</li><li>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.</li><li>Serve as a resource for training junior quality engineers.</li><li>Work with outside labs and suppliers to communicate Smith &amp; Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.</li><li>Support Post Market Surveillance activities, Management Review, and audits/inspections.</li><li>Assist in other responsibilities requested by management to ensure compliance.</li></ul><p>What will you need to be successful?</p><p></p><p>Bachelor’s degree in science, engineering, or other related field</p><p>Minimum 5 years experience in the pharmaceutical/medical device industry or related regulated industry. Experience in equipment qualification/process validation, and measurement system analysis preferred.</p><p>Portuguese and English proficient</p><p></p><p>Competencies:</p><ul><li>Need to be able to make sound decisions with attention to details</li><li>Understanding the impact of regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.) on Smith &amp; Nephew’s products is necessary</li><li>Must be able to provide and implement solutions to quality problems</li><li>Ability to plan and schedule multiple projects and tasks</li><li>Effective written/oral communication skills</li><li>Team player</li><li>MS Office, MS Excel, and Statistical software proficiency</li></ul><p></p><p>Travel Requirements:  </p><p>Up to 5% domestic</p><p></p><p>You. Unlimited.</p><p>We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.</p><ul><li>Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.smith-nephew.com%2F&amp;data=05%7C01%7CAnna.Rosell%40smith-nephew.com%7C090c23607e5e4c46d78808dbeff87648%7C273106dc287842ebb7c8069dcf334687%7C0%7C0%7C638367622634899921%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2lu