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Pulau Pinang, Malaysia
Hybrid
Engineer 2, 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.
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.
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.
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.
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.
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.
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?
The Quality Engineer is responsible for leading sustaining quality activities and supporting new product transfers by ensuring manufacturing processes are capable, compliant, and deliver consistent product quality. The role focuses on process validation, risk management, regulatory compliance, and continuous improvement while supporting production and meeting customer quality expectations.
The ideal candidate should hold a Bachelor's degree in Engineering or a related technical field, with experience in manufacturing and regulated environments such as FDA and European standards. Strong knowledge of Lean, Six Sigma, statistics, risk management, process validation, and GMP/ISO requirements is essential, along with proven problem-solving, project leadership, data analysis, and cross-functional collaboration skills.
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
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