Quality Engineer: Process Excellence & Compliance

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

Benefits offered by this job

Work/Life Balance

Wellbeing Benefits

Hybrid Work Model

Training & Mentorship

Job summary

Smith Nephew Life Unlimited in Malaysia seeks an Engineer 2, Quality Engineering to support projects, ensure quality, reliability, and continuous improvement across products and manufacturing processes. The role involves DHR review, non-conformances, CAPAs, root cause analysis, and risk management to maintain regulatory compliance and drive operational excellence within a GMP/ISO framework.

Hybrid work model is offered; ideal candidate holds a Bachelor's degree in Engineering with manufacturing

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 requirements.

Responsibilities

• Lead sustaining quality activities and support new product transfers.
• Ensure process validation and risk management across manufacturing.
• Review Device History Records (DHR) and manage non-conformances, CAPAs, and customer complaints.
• Drive continuous improvement through quality metrics and control plans.

Skills

Lean

Six Sigma

Kaizen

PDCA

Education

Bachelor's degree in Engineering

Job description

Smith Nephew Life Unlimited in Malaysia seeks an Engineer 2, Quality Engineering to support projects, ensure quality, reliability, and continuous improvement across products and manufacturing processes. The role involves DHR review, non-conformances, CAPAs, root cause analysis, and risk management to maintain regulatory compliance and drive operational excellence within a GMP/ISO framework.

Hybrid work model is offered; ideal candidate holds a Bachelor's degree in Engineering with manufacturing