Engineer, Quality Control

Smith Nephew; Malaysia; Hybrid; MYR 60,000 - 120,000; Full time

Benefits offered by this job

Hybrid Work Model (Most roles)

Job summary

Smith Nephew seeks an Engineer, Quality Control to lead and continuously improve QC for raw materials, incoming and in-process inspections. You will ensure only compliant materials enter production through robust inspection systems, risk-based controls and continuous improvement initiatives.

You will collaborate with Supplier Quality, Operations, Manufacturing Engineering and Quality Engineering to proactively manage material-related quality risks, escalate issues, and drive CAPA and MRB

Qualifications

• Bachelor's degree in Engineering or related field.
• Strong knowledge of Quality Control and incoming inspection.
• Experience with risk-based sampling strategies and engineering specifications.
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 is important.

Responsibilities

• Develop and improve risk-based incoming inspection strategies and sampling plans.
• Improve inspection capacity, accuracy, cycle time and efficiency via data analysis and automation.
• Lead investigations and containment of raw material quality issues with escalation and CAPA.
• Manage Nonconforming materials and MRB, including investigations and corrective actions.
• Support training of QC inspectors and operations teams on inspection methods and acceptance criteria.
• Drive QC continuous improvement and digitalization initiatives.
• Ensure compliance and audit readiness with applicable standards and procedures.

Skills

Quality Control

Incoming Inspection

Risk-based Sampling

Data Analytics

CAPA & Investigations

Quality Tools

Education

Bachelor's degree in Engineering or related field

Tools

MSA

SPC

8D

DMAIC

Fishbone Analysis

Lean Six Sigma

Job description

Engineer, Quality Control

Life Unlimited. At Smith+Naphew, 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

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