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Performing quality audits as per ISO 9001and ISO 13485 and related harmonized standards (ISO 14971, IEC 62304, IEC 60601etc)
About the Role
Description
of the Job Profile (Role and Responsibility)Performing quality audits as per ISO 9001and ISO 13485 and related harmonized standards (ISO 14971, IEC 62304, IEC 60601etc)
Understanding of software lifecycle
Guiding andfacilitatingprojects for effective process &metricsimplementation
Work productreviews(Software Safety classification, DHF, Risk Management File, FMEA, DMR, Problem Reportsetc)for quality and process
Writing,updatingand implementation of quality management system
ConductingISO 13485 and harmonizedstandard’sprocesstrainings
Prepare & Present Management Reviews
Defining processes andconductQuality Management System related activities
Review documents (such as proposals / SoWs / Project plans) to ensure the quality
Take other global initiatives such as external audits, Customer surveys, knowledge management, tr...
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