Qae Engineer

Involve in Post Market Quality Reporting.
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.
Maintain the Risk Management files.
Other QA admin function, as identified.
Requirements:
Degree in science or equivalent.
Min 2 years in QA/QC.
Knowledge in ISO13485.
Experience in Complaint investigation.
Innovative, committed with good accountability.
About AmbuAmbu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.#J-18808-Ljbffr