Quality Engineer

**Life Unlimited.** At Smith+Nephew we design and manufacture technology that takes the limits off living.   Smith+Nephew is hiring **Quality Engineers.** Join our team as a Quality Engineer and help bring our “Life Unlimited” purpose to life by ensuring the quality of life-changing medical devices. You’ll take ownership of monitoring and improving quality performance through the effective application of statistical process control (SPC) and data-driven quality metrics, using insights to proactively identify risks, drive process stability, and enable continuous improvement. Working closely with manufacturing, engineering, and NPI teams, you will help embed a culture of quality excellence and informed decision-making. We’re looking for someone who combines strong technical capability with a proactive, problem-solving mindset.  A strong understanding of quality principles is essential, with proven experience in process monitoring and delivering measurable process improvements. **What will you be doing?** * Act as Quality Lead for a specific Manufacturing Value Stream. * Provide day‑to‑day quality engineering support to manufacturing, ensuring timely resolution of nonconformances. * Lead structured root cause analysis using Six Sigma and Lean problem‑solving tools (5 Why, Fishbone, DMAIC, 8D). * Assist manufacturing in establishing and maintaining process controls, inspection plans, and quality checkpoints. * Conduct Measurement System Analysis (MSA) including Gage R&R studies to ensure measurement reliability. * Use statistical analysis to identify trends and recommend preventive actions. * Independently support change control including risk assessments, verification/validation, and documentation review. * Evaluate the quality impact of product and process changes and ensure compliance with regulatory requirements. * Support readiness activities for introduction of new or updated products/processes into manufacturing. * Support maintenance of risk management files (PFMEA, DFMEA, hazard analysis) across the product lifecycle. * Develop and execute validation plans and protocols for manufacturing processes, equipment, and inspection methods. * Perform process capability analysis (Cp, Cpk) and contribute to statistical experiment design (DOE). * Act as subject matter expert during audits and support preparation activities. * Lead or contribute to CAPA initiatives with strong root cause analysis and verification of effectiveness. * Ensure excellent documentation aligned with GDP and regulatory expectations. * Collect, analyse, and interpret data related to quality performance (scrap, defects, yields, complaints). * Prepare and present quality metrics to cross‑functional stakeholders. * Lead and support Six Sigma–based continuous improvement projects focused on yield improvement, defect reduction, and process capability enhancement. * Conduct structured investigations into returned products and customer complaints. * Collaborate with suppliers, test labs, and engineering functions to resolve issues. * Partner with Manufacturing, R&D, NPI, DQA, process engineering and QC to apply quality principles across the product lifecycle. **What will you need to be successful?** * Bachelor’s degree in Engineering, Science, or a related technical discipline required (eg, Chemical Engineering, Materials Science). * Experience in a regulated industry (medical devices preferred). * Demonstrated experience applying Six Sigma tools (e.g., DMAIC, MSA, SPC, DOE, capability analysis). * Experience conducting Measurement System Analysis and Gage R&R studies. * Experience with root cause analysis, validation, and risk management. * Strong analytical skills and ability to interpret technical data. * Effective communication and cross‑functional collaboration skills. **Preferred** Lean Six Sigma Green Belt certification 2–5 years of quality engineering experience in a regulated environment. Experience with CAPA ownership and statistical data analysis. Familiarity with design transfer and sustaining engineering processes. **You. Unlimited.** We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. **Inclusion and Belonging**: Committed to welcoming, celebrating and thriving on inclusion and belonging. Learn more about our Employee Inclusion Groups on our website (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. **Extra Perks:** Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts. Hybrid role Stay connected by joining our [Talent Community](https://smithnephew.wd5.myworkdayjobs.com/External/page/4ba17039009510002b17ea5e89c40000). We're more than just a company - we're a community! Follow us on [LinkedIn](https://www.linkedin.com/company/smith-&-nephew/) to see how we support and empower our employees and patients every day.   Check us out on [Glassdoor](https://www.glassdoor.com/Overview/Working-at-Smith-and-Nephew-EI_IE10233.11,27.htm) for a glimpse behind the scenes and a sneak peek into **You. Unlimited.**, life, culture, and benefits at S+N. Explore our [website](https://www.smith-nephew.com/en/) and learn more about our mission, our team, and the opportunities we offer.