Quality Engineer
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living
The Quality Engineer leads and manages engineering projects that require advanced technical expertise, applying a wide range of engineering principles across complex assignments. This role may involve supervising technical staff and supporting their development while ensuring project success. The engineer is expected to work independently, using specialized knowledge to drive improvements and solve problems.
In this role, the Quality Engineer applies quality engineering tools throughout the product lifecycle, from development and transfer to maintenance. They are responsible for enhancing product and process reliability, managing risks, and aligning with business and quality objectives. Additionally, they review Device History Records (DHR) for shipment, analyze non-conformances and customer complaints, and assist in root cause investigations and reporting.
What will you be doing?
The Quality Engineer plays a critical role in driving business improvements through the application of Lean, Six Sigma, PDCA, and other continuous improvement tools. They support product and process characterizations to improve cost efficiency and quality, while also developing the necessary skill sets for new product introductions and lifecycle management. By conducting benchmarking and implementing best practices, the Quality Engineer contributes to enhancing overall quality performance across the organization.
In the area of compliance, the Quality Engineer ensures adherence to global regulatory standards such as FDA 21 CFR, ISO 13485, MDD, and others. They support audits, conduct line inspections, and validate corrective and preventive actions to maintain high-quality standards. Additionally, the role involves collaboration with R&D and cross-functional teams during new product development, applying design controls, risk management, and root cause analysis to support smooth design transfer and robust product launches.
On the manufacturing floor, the Quality Engineer is responsible for product/process qualification, production control plans, and material disposition. They lead non-conformance investigations, CAPA management, and metrics tracking while ensuring effective risk mitigation and validation practices. This includes developing measurement systems, conducting statistical analysis, and ensuring appropriate process controls are in place to support patient safety and product reliability. The role also entails compliance with health, safety, and environmental policies and may involve leading strategic or ad hoc quality-related projects.
What will you need to be successful?
The Quality Engineer role requires a Bachelor's Degree in Engineering or a related technical field, with a minimum of four years of relevant experience, preferably in manufacturing or operations within FDA and European regulatory environments. The role demands strong technical skills, including knowledge of risk management, process validation, GMP/ISO standards, and proficiency in statistical tools such as Six Sigma, SPC, DOE, and Minitab. Experience in New Product Introduction (NPI), troubleshooting, and hands-on problem solving is highly valued.
The ideal candidate must demonstrate excellent communication skills in English, with the ability to interpret technical documents, write reports, and present information clearly to various stakeholders. Advanced mathematical and analytical capabilities are essential, especially in applying statistical techniques for quality improvements and decision-making. Strong reasoning skills and project leadership experience are also necessary to manage quality systems and continuous improvement initiatives effectively.
Physically, the role requires time spent on the production floor and at a computer, along with the ability to use precision measuring tools. Good vision and hearing are important for inspection and communication. The work environment is generally safe, with a quiet to moderate noise level, and travel requirements are minimal—less than 10%. Reasonable accommodations are available for individuals with disabilities.
You.Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing: Medical, Dental, Vision, Health Savings Account, Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Flexibility: Hybrid Work Model (For most professional roles)
Training: Hands-On, Team-Customized, Mentorship
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