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- Senior
About the role
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 control.
- Innovative, committed with good accountability.
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