Senior Quality Engineer( Level-2)

**Position:**
Senior Quality Engineer( Level-2)

**Job Description:**

+ *** Detailed Description of the Job Profile (Role and Responsibility)** Performing quality audits as per ISO 9001 and ISO 13485 and related harmonized standards (ISO 14971, IEC 62304, IEC 60601 etc)

+ Understanding of software lifecycle

+ Guiding and facilitating projects for effective process & metric s implementation

+ Work product reviews(Software Safety classification, DHF, Risk Management File, FMEA, DMR, Problem Reports etc) for quality and process

+ Writing, updating and implementation of quality management system

+ Conducting ISO 13485 and harmonized standard’s process trainings

+ Prepare & Present Management Reviews

+ Defining processes and conduct Quality Management System related activities

+ Review documents (such as proposals / SoWs / Project plans) to ensure the quality

+ Take other global initiative...