Quality Engineer II: Process Excellence & Compliance

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

Health Savings Account

Parental Leave

Fertility and Adoption Assistance

Training: Hands-On

Job summary

Smith+Nephew in Penang is seeking a Quality Engineer to support manufacturing projects and ensure quality, reliability, and continuous improvement of products and processes. You will apply quality engineering principles, risk management, and problem-solving throughout the product lifecycle to maintain compliance and drive operational excellence.

Responsibilities include reviewing DHRs, handling non-conformances and CAPAs, and supporting new product introductions with appropriate design controls

Qualifications

• Bachelor's degree in Engineering or related technical field, with manufacturing/regulatory exposure.
• Strong knowledge of Lean, Six Sigma, risk management, GMP/ISO requirements.
• Demonstrated problem solving, project leadership, data analysis, and cross‑functional collaboration.

Responsibilities

• Support engineering projects and ensure quality, reliability, and continuous improvement of products and processes.
• Review and approve Device History Records (DHR) for product shipment and investigate non-conformances.
• Lead CAPAs, root cause analyses, and corrective actions to maintain compliance.
• Assist with design transfers, risk management, and design controls for new products.
• Monitor quality metrics, process capability, and product quality across manufacturing.
• Promote compliance with HSE, Sustainability, and Energy policies; report incidents.
• Collaborate with R&D and cross‑functional teams on product introductions and validations.
• Support process validation (IQ, OQ, PQ) and creation of control & sampling plans.

Skills

Problem-solving

Cross-functional collaboration

Data analysis

Project leadership

Lean

Six Sigma

Regulatory knowledge

Education

Bachelor's degree in Engineering or related technical field

Job description

Smith+Nephew in Penang is seeking a Quality Engineer to support manufacturing projects and ensure quality, reliability, and continuous improvement of products and processes. You will apply quality engineering principles, risk management, and problem-solving throughout the product lifecycle to maintain compliance and drive operational excellence.

Responsibilities include reviewing DHRs, handling non-conformances and CAPAs, and supporting new product introductions with appropriate design controls