Smith+Nephew
medical devices
QualityEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Engineer at Smith+Nephew. Skills: Quality engineering, Six Sigma, Statistical analysis. Act as Quality Lead. Provide quality engineering support”
What You'll Achieve.
Ensuring the quality of life-changing medical devices; Monitoring and improving quality performance; Proactively identify risks; Drive process stability; Enable continuous improvement; Embed a culture of quality excellence; Deliver measurable process improvements; Timely resolution of nonconformances; Ensure compliance with regulatory requirements; Yield improvement; Defect reduction; Process capability enhancement
Industry & Context.
Problem-solving mindset; Root cause analysis
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, Science, or a related technical discipline, Experience in a regulated industry, Demonstrated experience applying Six Sigma tools, Experience conducting Measurement System Analysis and Gage R&R studies, Experience with root cause analysis, validation, and risk management, analytical skills and ability to interpret technical data, Effective communication and cross‑functional collaboration skills
Nice to Have
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
What You'll Do.
Provide quality engineering support
Lead root cause analysis
Assist manufacturing with process controls
Conduct Measurement System Analysis
Use statistical analysis
Support change control
Evaluate quality impact
Support readiness activities
Support risk management files
Develop validation plans
Perform process capability analysis
Act as subject matter expert
Lead CAPA initiatives
Collect and analyze data
Prepare quality metrics
Lead continuous improvement projects
Conduct investigations
Collaborate with suppliers
Apply quality principles
How You'll Work.
Team & Collaboration
Working closely with manufacturing, engineering, and NPI teams; Collaborate with suppliers, test labs, and engineering functions; Partner with Manufacturing, R&D, NPI, DQA, process engineering and QC
Communication Scope
Effective communication; Present quality metrics
Process & Methodology
CAPA initiatives
Full Job Description
**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
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