Quality Engineer II: Process Excellence & Compliance

Smith & Nephew; George Town; On-site; MYR 60,000 - 120,000; Full time

Benefits offered by this job

Flexible time off

Health & wellbeing benefits

Parental leave

Job summary

Smith & Nephew is seeking a Quality Engineer in Malaysia to support manufacturing quality, risk management, and continuous improvement across the product lifecycle.

The role collaborates with R&D, operations, and regulatory teams to ensure compliant processes, device history records, and robust quality metrics are maintained. A strong Lean/Six Sigma background and GMP/ISO knowledge are essential.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Experience in manufacturing and regulated environments (FDA/European standards).
• Strong knowledge of Lean, Six Sigma, statistics, risk management, GMP/ISO.
• Proven problem-solving and project leadership.

Responsibilities

• Lead sustaining quality activities and support new product transfers.
• Ensure manufacturing processes are capable, compliant, and deliver consistent quality.
• Support process validation, risk management, regulatory compliance, and continuous improvement.
• Assist production and meet customer quality expectations.
• Support audits, CAPAs, and corrective actions as needed.

Skills

Lean

Six Sigma

Kaizen

PDCA

Risk management

Process validation

CAPA

Root cause analysis

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Job description

Smith & Nephew is seeking a Quality Engineer in Malaysia to support manufacturing quality, risk management, and continuous improvement across the product lifecycle.

The role collaborates with R&D, operations, and regulatory teams to ensure compliant processes, device history records, and robust quality metrics are maintained. A strong Lean/Six Sigma background and GMP/ISO knowledge are essential.