Quality Engineer

Smith & Nephew; Hull and East Yorkshire; On-site; GBP 38,000 - 60,000; Full time

Benefits offered by this job

Annual bonus

Pension scheme

Share options

Flexible vacation

Health plan

Dental plan

Hybrid work model

Mentorship program

Employee discounts

Job summary

Smith+Nebrew is hiring a Quality Engineer to drive quality performance for a Manufacturing Value Stream. You will apply SPC and data-driven metrics to identify risks, improve processes, and support continuous improvement initiatives across manufacturing, engineering and NPI teams.

The role requires a strong Six Sigma background, root-cause analysis, change control, and a solid regulatory mindset. You will work in a hybrid setup with a focus on quality excellence and informed decision-making.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Experience in a regulated industry (medical devices preferred).
• Demonstrated Six Sigma tools experience (DMAIC, MSA, SPC, DOE, capability analysis).
• Experience with root cause analysis, validation, and risk management.
• Strong analytical skills and ability to interpret technical data.
• Effective communication and cross‑functional collaboration.

Responsibilities

• Act as Quality Lead for a specific Manufacturing Value Stream.
• Provide day‑to‑day quality engineering support to manufacturing.
• Lead root cause analysis using Six Sigma and Lean tools (5 Why, Fishbone, DMAIC, 8D).
• Establish and maintain process controls, inspection plans, and checkpoints.
• Conduct MSA including Gage R&R studies for measurement reliability.
• Use statistical analysis to identify trends and recommend preventive actions.
• Support change control including risk assessments and documentation review.
• Evaluate quality impact of product/process changes and ensure regulatory compliance.
• Support readiness for new or updated products/processes in manufacturing.
• Lead CAPA initiatives with strong root cause analysis and verification.

Skills

Quality engineering

Six Sigma tools

Statistical analysis

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Science

Tools

MSA

Gage R&R

DMAIC

8D

Job description

Life Unlimited. At Smith+Nebrew we design and manufacture technology that takes the limits off living. Smith+Nebrew 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 Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nebrew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nebrew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can‑do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.