Job Description

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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