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 control.
