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
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