Quality Engineer

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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