- Handle customer's feedback/ complaints, conduct failure investigation, work with site engineer to perform simulation where required, to resolve quality feedback.
- Involved in product review revalidation, CAPA activities as assigned.
- Compile investigation report, response to initiator and advice product manager on critical issue as required.
- Perform routine data analysis as appropriate for routine monitoring of product quality.
- Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements.
- Lead medical devices Risk Management Process and maintain the Risk Management files.
- As Agile change analyst for related project.
- Other QA admin function, as identified.
- Degree in science or equivalent
- Min 2 years in QA/QC
- Knowledge in ISO13485
- Experience in Complaint investigation
- Knowledge in Process validation
- Innovative, committed with good accountability
QAE Engineer - Penang, Malaysia - Ambu A/S
