Engineer, Quality Control

Smith & Nephew; Malaysia; Hybrid; MYR 110,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Medical, Dental, Vision

Parental Leave

Fertility and Adoption Assistance

Training and Mentorship

Job summary

Smith+Nephew is seeking an Engineer in Quality Control in Malaysia. The role focuses on managing and improving QC for raw materials, incoming and in-process inspections, ensuring only compliant materials enter production.

You will work with Supplier Quality, Operations, and Manufacturing Engineering to mitigate material-related risks and drive CAPA and MRB processes. The ideal candidate has 5–8 years of experience in Quality Engineering or QC within regulated manufacturing, with knowledge of ISO

Qualifications

• Requires a Bachelor’s degree in Engineering or related field.
• Strong knowledge of Quality Control, incoming inspection, raw material quality, inspection methods, and risk-based sampling strategies.

Responsibilities

• Develop and implement risk-based incoming inspection strategies and sampling plans.
• Improve inspection capacity, accuracy, cycle time, and efficiency through validated methods and data analytics.
• Lead investigations and containment of raw material quality issues with escalation and CAPA.
• Manage Material Review Board and nonconforming materials; drive CAPA and MRB processes.
• Support training and capability development for QC inspectors and Operations teams.
• Drive continuous improvement and digitalization of QC processes and inspection practices.
• Ensure compliance with standards and regulations; maintain audit readiness.

Skills

Quality control

Incoming inspection

Risk-based sampling

MSA

SPC

8D

CAPA

MRB

Lean Six Sigma

Data analytics

Education

Bachelor's degree in Engineering

Tools

MSA

SPC

8D

DMAIC

Job description

**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**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