Participate in product failure investigation from market feedback of existing/new devices, work with supplier / Ambu's manufacturing sites / project team / R&D and/or NPI team to replicate the reported failure and identify the cause of the product failure.
Conduct meeting with supplier and/or counterpart from other Ambu's sites to assist in complaint investigation if required.
Review the response of product failure investigation from supplier and/or counterpart from other Ambu's sites and conclude / complete the complaint investigation reporting.
Involve in top 80% defect analysis from market complaint and compile the analysis report.
Work with QM R&D / QM Operation - to provide input in the update of product / process risk document that initiated due to market complaint.
Involve in CAPA / NCR / Planned Deviation as required.
Involve in other QM function as identified.
Requirement
Degree in science / engineering or equivalent.
Min 2 years in QA / QC background.
Understanding in ISO 13485.
Experience in product failure investigation and report compilation.
Good communication skill, committed with good accountability, flexible & willing to learn new knowledge, good collaboration and team spirit.
