Engineer 1, Quality Engineering

Smith+Nephew is hiring an Engineer 1, Quality Engineering. Level rates it ; you can apply on Smith+Nephew.

Level's read on this job

Level rates this role Little AI ●○○○: aI is not part of the work.
Tools and skills the posting cites include Lean, Six Sigma and quality engineering.
Level classifies it as a junior role.
Level lists 361 other open roles at Smith+Nephew.
The role was posted in the last few days.

AI in this role

Support engineering projects, ensure product quality and compliance, and drive continuous improvement initiatives in manufacturing.

LeanSix Sigma

quality-engineeringrisk-managementroot-cause-analysisprocess-validation

Engineer 1, Quality Engineering

Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.

The Quality Engineer is responsible for supporting engineering projects and ensuring the quality, reliability, and continuous improvement of products and manufacturing processes. The role applies quality engineering principles, risk management, and problem-solving techniques throughout the product lifecycle to maintain compliance and drive operational excellence.

The position also reviews and approves Device History Records (DHR) for product shipment, investigates non-conformances and customer complaints, and supports root cause analysis and corrective actions. Working closely with cross-functional teams, the engineer helps improve process capability and product quality while supporting day-to-day manufacturing operations.

In addition, the role promotes compliance with Health, Safety, Environment (HSE), Sustainability, and Energy policies. This includes preventing workplace injuries, environmental incidents, and energy wastage, as well as reporting HSE incidents and contributing to continuous improvement initiatives.

What will you be doing?
Business Improvements

Supports continuous improvement initiatives by applying quality tools such as Lean, Six Sigma, Kaizen, and PDCA to enhance product quality, process efficiency, and cost effectiveness. Also benchmarks best practices and develops quality engineering capabilities to support business growth.

Compliance / Regulatory

Ensures products and manufacturing processes comply with global regulatory requirements and quality standards. Supports audits, conducts production line assessments, and drives corrective and preventive actions to maintain compliance.

New Product / Process Introduction

Works closely with R&D and cross-functional teams to support new product introductions and design transfers, ensuring appropriate design controls, risk management, and product quality requirements are met.

Product Quality, Control & Disposition

Leads material review activities and manages non-conformances, CAPAs, and customer complaints. Responsible for root cause investigations, quality metrics, defect management, and maintaining Device History Records (DHR) to ensure product quality and compliance.

Product / Process Qualification

Supports process validation and qualification activities, including IQ, OQ, PQ, TMV, and software validation. Develops control plans, sampling plans, measurement systems, and process monitoring methods to ensure process capability and product quality.

Risk Mitigation

Evaluates process changes and quality risks to prevent non-compliance and product failures. Applies risk management principles to assess controls, implement mitigation measures, and ensure ongoing product safety and quality.

Strategic

Develops and supports quality strategies for product, process, and test method validation. Participates in strategic initiatives and special projects assigned by management to support business objectives and continuous improvement efforts.

What will you need to be successful?

This role leads sustaining quality performance and new product transfer activities, ensuring manufacturing processes are capable, validated, compliant, and effectively managed for risk. It requires strong cross-functional coordination to maintain production continuity, meet customer quality expectations, and deliver projects on time, with hands-on troubleshooting and sound technical decision-making.
The ideal candidate has a Bachelor’s Degree in Engineering or a related technical field, with relevant manufacturing/operations experience. Strong knowledge of Lean, Six Sigma, SPC, MSA, DOE, Reliability, FDA/ISO risk management, GMP, NPI, and Process Validation is important, along with statistical data analysis, project leadership, and experience implementing effective risk-mitigation strategies in regulated environments.

You.Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/

Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

Your Wellbeing: Medical, Dental, Vision, Health Savings Account , Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

Flexibility: Hybrid Work Model (For most professional roles)

Training: Hands-On, Team-Customized, Mentorship

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.

How we rate this

Engineer 1, Quality Engineering at Smith+Nephew rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Key facts

Engineer 1, Quality Engineering is an open job at Smith+Nephew.
Level rates this role AI Level 1 of 4: Little AI.
The role is based in MYS - Penang.
The job was posted on November 11, 2026.
Seniority: junior.
Applications are handled by Smith+Nephew. Apply on Smith+Nephew

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Quality EngineeringRisk ManagementRoot Cause AnalysisProcess ValidationLeanSix Sigma

Questions you could be asked

Tell me about a project where quality engineering was part of your work. What did you do?
Tell me about a project where risk management was part of your work. What did you do?
Tell me about a project where root cause analysis was part of your work. What did you do?
Tell me about a project where process validation was part of your work. What did you do?
Walk me through how you've used Lean in your day-to-day work.

Adapt your resume

List these exact terms on your resume: Quality Engineering, Risk Management, Root Cause Analysis, Process Validation, and Lean. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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