Quality Engineer II — Hybrid & Process Excellence

Smith & Nephew; Penang; Hybrid; MYR 67,000 - 100,000; Full time

Benefits offered by this job

Hybrid Work Model

Medical

Dental

Vision

Health Savings Account

Parental Leave

Fertility and Adoption Assistance

Job summary

Smith+ Nephew in Penang invites a Quality Engineer to join our Life Unlimited team. You will support engineering projects, ensure quality and reliability of products and processes, review DHRs, investigate non-conformances, and drive continuous improvement across the product lifecycle.

You will apply Lean, Six Sigma and risk management, collaborate with R&D and operations, and ensure compliance with GMP/ISO standards while promoting HSE, sustainability and energy policies.

Qualifications

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

Responsibilities

• Apply quality tools (Lean, Six Sigma, Kaizen, PDCA) to improve product quality, process efficiency, and cost effectiveness.
• Ensure regulatory compliance and support audits, line assessments, CAPAs.
• Support new product introductions and design transfers with design controls.
• Lead material review, manage non-conformances, CAPAs, and DHR maintenance.
• Support QA activities, risk assessment, and process validation (IQ/OQ/PQ/TMV).
• Promote HSE, sustainability and energy policies in manufacturing.

Skills

Lean

Six Sigma

Statistics

Risk management

Process validation

GMP/ISO

Problem solving

Project leadership

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related technical field

Job description

Smith+ Nephew in Penang invites a Quality Engineer to join our Life Unlimited team. You will support engineering projects, ensure quality and reliability of products and processes, review DHRs, investigate non-conformances, and drive continuous improvement across the product lifecycle.

You will apply Lean, Six Sigma and risk management, collaborate with R&D and operations, and ensure compliance with GMP/ISO standards while promoting HSE, sustainability and energy policies.