QAE Engineer

at  Ambu

REQUIREMENTS:

• 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

• 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.