Job Description

Senior Engineer, Quality EngineeringLife Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.The Quality Engineer plans, conducts, and advises engineering projects or studies, including comprehensive projects requiring sophisticated knowledge of an outstanding field, particularly on Process Validations. This role demands extensive expertise in Process Validations. They apply a broad and diverse understanding of engineering principles and practices across various assignment areas, often coordinating and advising the activities of technical support staff. Additionally, they are accountable for the technical development of the assigned staff.The Quality Engineer employs Quality Engineering tools and practices to efficiently develop, transfer, and maintain products/processes throughout the product lifecycle. They apply Quality Engineering principles and problem-solving skills to improve and sustain products/processes in alignment with the overall Quality and Business vision. Moreover, they apply appropriate risk management strategies to prevent unforeseen failure modes and improve process capability. This individual provides crucial support to processes in the base business.What will you be doing?Business Improvements - support quality improvement initiatives, reviewing and analyzing the efficiency of improvement tools like PDCA, Six Sigma, etc. Conduct benchmarking and support development of quality engineering for new product introductions.Compliance/Regulatory - review and analyze compliance to global regulations and standards, supporting internal and external audits, and conducting periodic line audits.New Product/Process Introduction - partner with R&D for accurate application of design controls and support new product introduction processes.Product Quality, Control & Disposition, Performance Standards - lead Material Review Board, investigate and approve non-conformances, CAPAs, and customer complaints. Analyze corrective actions and maintain Device History Records.Product/Process Qualification - guide in process validation, ensuring accurate qualification of products and processes.Production/Process Controls including Control Plans - partner with various departments to ensure process validation and control plans, develop measurement systems, and conduct analytical/statistical analysis.Risk Mitigation - document, review, and analyze proposed process changes to mitigate risks and ensure compliance.Strategic - develop effective quality strategies for validation of test methods, processes, and designs.HSE Compliance - align with HSE policies, regulations, and rules to prevent safety, health, and environmental issues, reporting incidents for improvement.Other Job Functions - perform non-essential duties as assigned by the Supervisor and may undertake special projects commensurate with experience.Qualification Requirements - successful performance requires satisfactory completion of crucial duties, with knowledge, skills, and abilities in the job\'s demands. Reasonable accommodations can be made for individuals with disabilities.What will you need to be successful?The Quality Engineer assumes a significant role in orchestrating, overseeing, and executing engineering projects centered on Process Validations. With extensive proficiency in Quality Engineering tools and practices, they guarantee the efficient evolution, transfer, and upkeep of products/processes across their lifecycle.Responsibilities encompass supporting quality improvement initiatives, ensuring compliance with regulatory standards, and collaborating with cross-functional teams for new product introductions. They are also accountable for product quality, control, and disposition, including leading Material Review Boards and handling customer complaints. Risk mitigation, strategic planning, and adherence to HSE policies are integral aspects of the role.The position requires a Bachelor\'s degree in Engineering or a related field, with at least 5 years of proven experience, preferably in an FDA and European regulatory environment. Strong proficiencies in statistical methodologies, problem-solving, and project management are critical.Proficiency in English and sophisticated mathematical skills are also vital. Physical demands include walking, standing, and computer work, with occasional travel requirements. The work environment is typically quiet to moderate.You. Unlimited.We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (https://www.smith-nephew.com/)Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.Flexibility: Hybrid Working Model (For most professional roles).Training: Hands-On, Team-Customised, Mentorship.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.

Smith & Nephew