Reporting into the Quality Department, this role has responsibility for Quality related actions in support of Andover Products (Design Quality). This position will implement, support, and sustain elements of Smith & Nephew’s Quality System through procedure generation, training, auditing, and technical support. The Senior Quality Engineer determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for ISO, MDD/MDR, and QSR requirements. Works collaboratively with project team members to develop and manage project plans. Champion design control and risk management activities for assigned projects. Evaluate risk and verification implications for post launch design changes. Continuously improve Design Control procedures and maintain procedural compliance.
Supports on-market product to ensure delivery of safe and effective products to our customers by ensuring product changes and other support activities comply with design control procedures and regulations, as well as the requirements of ISO, MDD/MDR, and QSR regulations and standards. Key deliverables include but are not limited to: risk management, product performance analysis on similar products, design verification / validation including software validation, design transfer to manufacturing, DHF tracking and completion, and product release authorization for distribution. This responsibiliy includes the identification of necessary inspection, test, and audit procedures; identification of needed reliability testing; identification, procurement, and maintenance of needed engineering test equipment; and support of process/product validation. Responsible for development and release of engineering design documentation.
Support manufacturing operations and supplier quality and provide expertise in product requirements, risk management, test methods, and statistical analysis. Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier. Maintain inspection/testing to ensure that incoming, in-process, and finished products meet functional specifications and quality standards. Ensure completeness, accuracy, and testability of product requirements (Control plans, Measurement Systems Analysis, datasheets, inspection instructions, etc).
Assist in preparation for regulatory submissions, and present Design Control elements during internal and external audits.
Leads the review of field complaints and feedback, assists in the analysis and the development of corrective actions; monitors and reports complaint trend analysis. Partners with the Post Market Surveillance group and Clinical Evidence group in the support of PMSR and CER updates. Maintain Risk Management Files for site in compliance with procedures.
Evaluate all post launch proposed design changes to determine impact on risk level, verification and/or validation testing.
Support CAPA, Quality Hold, NCMR, and Health Hazard Evaluation processes as required.
Lead continuous improvement activities including contributing to system level procedural requirements/updates as needed.
Works cross-functionally to influence key stakeholders and provides training, leadership and mentorship to teams and junior QEs
Education: BS in Engineering or technically related field
Licenses/Certifications:CQE and Six Sigma certification preferred
Experience: 5-8 years Quality Engineering experience in Medical Device Industry
Smith & Nephew is a global advanced medical technology business. We support healthcare professionals in more than 100 countries to improve the quality of life for their patients. Since 1856, when our founder T.J. Smith developed a new method for refining cod liver oil, and in World War One when his nephew led the supply of wound care products, to the present day, Smith & Nephew continues to pioneer health solutions.
Through our market leadership positions in Sports Medicine, Trauma, Orthopaedic Reconstruction and Advanced Wound Management, our 16,000 employees continue to improve outcomes and expand access, constantly striving to create value for healthcare professionals, patients, payers and shareholders
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