Smith+Nephew
Engineer, Quality Control
Malaysia · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerSmith+Nephew
- LocationMalaysia
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
Engineer, Quality Control
Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.
Responsible for managing and continuously improving Quality Control (QC), with a focus on raw materials, incoming and in-process inspections. Ensures only compliant materials enter production through effective inspection systems, risk-based controls, escalation, and continuous improvement. Works closely with Supplier Quality, Operations, Manufacturing Engineering, and Quality Engineering to proactively manage and contain material-related quality risks.
What will you be doing?
Raw Material Quality & Incoming Inspection
Develop and improve risk-based incoming inspection strategies, sampling plans, and inspection readiness based on supplier performance, material criticality, specifications, and quality trends.
Inspection System Effectiveness & Capability
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Improve inspection capacity, accuracy, cycle time, and efficiency through MSA, validated inspection methods and tools, data analysis, digitalization, and automation.
Raw Material Issue Escalation
Lead investigation and rapid containment of raw material quality issues, including escalation, root-cause analysis, and corrective actions with Supplier Quality and Operations.
Nonconformance & Material Control
Manage the Material Review Board and nonconforming materials, including investigation, segregation, CAPA, complaints, corrective and preventive actions, and quality metrics.
Training & Capability Building
Support training and competency development for QC inspectors and Operations teams on inspection methods, defect classification, sampling plans, and acceptance criteria.
Continuous Improvement & Digitalization
Drive improvements in QC efficiency, automation, digitalization, data analytics, and inspection best practices.
Compliance & Audit Readiness
Ensure incoming inspection activities comply with applicable standards, regulations, and internal procedures while maintaining documentation, traceability, and audit readiness.
What will you need to be successful?
- Requires a Bachelor’s degree, preferably in Engineering or a related field, with strong knowledge of Quality Control, incoming inspection, raw material quality, inspection methods, risk-based sampling strategies, and engineering specifications.
- The ideal candidate should have practical knowledge of quality tools and methodologies such as MSA, SPC, data analytics, 8D, 5-Why, Fishbone Analysis, DMAIC, CAPA, and MRB. A good understanding of ISO 13485 and FDA 21 CFR Part 820, together with Lean and Six Sigma principles, is important for managing nonconformances, investigations, corrective actions, and continuous improvement.
- Requires 5–8 years of experience in Quality Engineering or Quality Control within a regulated manufacturing environment, preferably in the medical device industry. Experience in incoming inspection, inspection planning, supplier/material quality issues, and improving inspection efficiency and accuracy is required, with exposure to training or coaching QC inspectors or production personnel preferred.
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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At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked