Engineer, Quality Control

Smith & Nephew; Penang; Hybrid; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid Work Model

Medical insurance

Dental insurance

Vision insurance

Parental Leave

Job summary

Smith+Neph is seeking an Engineer for Quality Control to manage and continuously improve QC across raw materials, incoming inspections, and in-process checks. You will work with Supplier Quality, Operations, Manufacturing Engineering, and Quality Engineering to proactively manage material quality risks.

You will lead risk-based inspection strategies, improve inspection systems, and drive CAPA and MRB processes while supporting training and upskilling of QC teams. A hybrid work model is available.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5–8 years in Quality Engineering or Quality Control in regulated manufacturing.

Responsibilities

• Develop and improve risk-based incoming inspection strategies.
• Improve inspection capacity, accuracy, cycle time and efficiency.
• Lead investigation and containment of raw material quality issues.
• Manage the Material Review Board and nonconforming materials.
• Support training and competency development for QC inspectors and Operations teams.
• Drive QC improvements through automation, data analytics and digitalization.
• Ensure compliance with standards, regulations and internal procedures.

Skills

Quality Control

Incoming inspection

Risk-based sampling

Lean Six Sigma

Quality tools

Education

Bachelor's degree in Engineering

Tools

MSA

SPC

DMAIC

8D

CAPA

MRB

Job description

Engineer, Quality Control Life Unlimited

At Smith+ ... 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.

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving.

You.Unlimited.

Our Culture

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

Additional Information

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. Smith+Neph is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it's our people who make Smith+Neph a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it's our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We're a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.