Responsibilities

• Participate in new product development and project design change for global products.
• Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality.
• Handle change control, especially be the expert in process validation for global products.
• Participate in the critical quality issue which required QAE attention in the project as required.
• Involve in NCR/ CAPA activities as required.
• Maintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change.
• Other QM R&D function, as identified.

Requirements

• Degree in science or equivalent.
• Min 2 years in Quality Assurance or Quality Engineering.
• Knowledge in ISO13485.
• Experience in product development, project management and/or design...