Quality Engineer

Smith Nephew; Hull and East Yorkshire; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Generous annual bonus

Pension schemes

Healthcare & dental plans

Employee discounts

Hybrid working model

Job summary

Smith Nephew in the UK is seeking a Quality Engineer to own the quality performance across a Manufacturing Value Stream. You will apply SPC, Six Sigma, and data-driven metrics to drive process stability, proactive risk identification and continuous improvement.

Collaborating with Manufacturing, Engineering, NPI, DQA and suppliers, you will embed a culture of quality excellence, maintain process controls, CAPA, risk management and robust documentation throughout the product lifecycle.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• Experience in a regulated medical devices environment is preferred.
• Proven experience applying Six Sigma tools (DMAIC, MSA, SPC, DOE, capability analysis).
• Experience with measurement system analysis and Gage R&R studies.
• Strong root cause analysis, validation, and risk management skills.
• Analytical mindset with ability to interpret technical data and communicate across functions.

Responsibilities

• Act as Quality Lead for a specific Manufacturing Value Stream.
• Provide day-to-day quality engineering support to manufacturing and resolve nonconformances.
• Lead structured root cause analysis using Six Sigma and Lean tools.
• Establish and maintain process controls, inspection plans, and quality checkpoints.
• Conduct MSA including Gage R&R to ensure measurement reliability.
• Use statistical analysis to identify trends and advise preventive actions.
• Support change control, risk assessments, validation, and documentation review.
• Evaluate quality impact of product/process changes and ensure regulatory compliance.
• Prepare and present quality metrics to cross-functional stakeholders.
• Lead CAPA initiatives with robust root cause analysis and effectiveness verification.

Skills

Six Sigma

SPC

Quality principles

Root cause analysis

Data-driven decision making

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

MSA

Gage R&R

DOE

DMAIC

CAPA

Job description

Life Unlimited. At Smith+Ne we design and manufacture technology that takes the limits off living.

Smith+Ne 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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