Quality Engineer II — Process Excellence & Compliance

Smith+Nephew; Penang; Hybrid; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid Work Model

Medical, Dental, Vision

Job summary

Smith+Nephew in Penang is seeking an Engineer 2, Quality Engineering to support quality, reliability, and continuous improvement across products and manufacturing processes. The role involves reviewing DHRs, investigating non-conformances, and leading CAPAs while ensuring compliance with GMP/ISO standards.

A Bachelor’s degree in engineering is required, with a focus on risk management and process validation.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Experience in manufacturing and regulated environments (FDA/European standards) is preferred.
• Strong knowledge of Lean, Six Sigma, statistics, risk management, and GMP/ISO requirements.

Responsibilities

• Lead sustaining quality activities and support new product transfers to ensure capable, compliant processes.
• Review and approve Device History Records (DHR) and manage non-conformances and CAPAs.
• Perform root cause investigations and drive corrective actions to improve quality metrics.
• Support process validation, risk assessment, and design transfers with cross-functional teams.

Skills

Quality engineering

Lean

Six Sigma

Data analysis

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Job description

Smith+Nephew in Penang is seeking an Engineer 2, Quality Engineering to support quality, reliability, and continuous improvement across products and manufacturing processes. The role involves reviewing DHRs, investigating non-conformances, and leading CAPAs while ensuring compliance with GMP/ISO standards.

A Bachelor’s degree in engineering is required, with a focus on risk management and process validation.