Quality Engineering EngineerLife Unlimited. At Smith+Nephew we craft and manufacture technology that takes the limits off living.What will you be doing?The Quality Engineer holds a pivotal role in planning, conducting, and directing engineering projects, necessitating sophisticated expertise in Process Validations. They possess extensive knowledge of engineering principles and practices, overseeing a broad spectrum of assignments. Additionally, they may supervise technical support staff and contribute to the technical development of their team. Utilizing Quality Engineering tools and practices ensures the effective development, transfer, and maintenance of products/processes across the product lifecycle.They employ problem-solving skills to improve products/processes in alignment with Quality and Business objectives, implementing risk management strategies to mitigate potential failures and enhance process capability. Furthermore, they provide support to processes in the base business.In Business Improvements, support quality enhancement initiatives for continuous cost improvements, including analyzing the effectiveness of improvement tools like PDCA, Six Sigma, and Lean Techniques. Conduct benchmarking to identify better quality improvement methods and assist in developing quality engineering and compliance skills for new product introductions and product life cycle management.What will you need to be successful?Ensure compliance with standards such as US FDA 21 CFR parts 820 & 4, ISO13485, Canadian Medical Device Regulation, European Medical Device Directive, ANVISA, TGA, Japan MHLW 169, and China GMP by reviewing and analyzing current products and processes. Champion adherence to global regulations and standards, providing support during internal and external audits. Conduct periodic line audits to evaluate production controls like lot segregation and review audit results to ensure the adequacy of corrective and preventive actions.In the realm of New Product/Process Introduction, the Quality Engineer collaborates with R&D and cross-functional teams to ensure effective application of design controls, risk management, and investigation of design challenges. They also support new product introduction as part of design transfer. In terms of Product Quality, Control & Disposition, they lead and maintain Material Review Board, handle non-conformances, CAPAs, and customer complaints, and ensure accountability for quality metrics and Device History Record maintenance. Additionally, they excel in Product/Process Qualification, Production/Process Controls, Risk Mitigation, and strategic quality strategies, while maintaining compliance with HSE policies and regulations.The Quality Engineer may also undertake non-essential job functions and special projects assigned by the Supervisor, demonstrating a dedication to excellence and continuous improvement. Qualification requirements include the ability to perform essential duties satisfactorily, with proficiency in various quality engineering domains. Reasonable accommodations may be provided to enable individuals with disabilities to perform these functions.Preferred Experience: Candidates with experience in both FDA and European regulatory environments, along with relevant manufacturing/operations experience, are sought after. Additionally, a proven track record of implementing effective risk mitigation strategies is essential.Technical Skills: Proficiency in Statistics, Lean, and Six Sigma methodologies is required, including expertise in Measurement System Analysis, SPC, DOEs, and Reliability. Candidates should possess in-depth knowledge of product/process Risk Management (FDA and ISO standards) and should be adept at using statistical software packages for data analysis and presentation.Competencies: Fluent English language skills are necessary for reading, analyzing, and interpreting technical documents and regulations, as well as for effective communication with stakeholders. Strong mathematical and reasoning abilities are also crucial for problem-solving and data analysis tasks. The role entails physical demands such as walking, standing, and using laboratory equipment, with the work environment typically being quiet to moderate in terms of noise level.Stay connected and receive alerts for jobs like this by joining our .We're more than just a company - we're a community! Follow us on to see how we support and empower our employees and patients every day.Check our for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.
