Senior Quality Engineer

Kuala Lumpur, Malaysia | Posted on 03/04/2026

• Industry Healthcare & Life Science - Medical Devices
• Work Experience 5+ years
• Country Malaysia

Job Description

• Lead quality planning activities for new projects, establish product line quality control plans, and develop inspection standards for raw materials, in-process stages, and finished goods.
  
• Perform in-process and final product inspections; compile inspection and batch production records; conduct compliance reviews; and ensure Device History Records (DHR) are complete, accurate, traceable, and properly archived.
  
• Maintain proper product inspection status control and ensure timely and appropriate disposition of non-conforming or held products.
  
• Carry out routine GMP compliance inspections within cleanroom environments and drive adherence to GMP standards in cleanroom operations.
  
• Facilitate cross-fu...