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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