Quality Engineer
Job Description:
Responsible for: . Analyzing, collecting data, and providing accurate, documented information
about the status of quality . Verifying the correctness of quality related development results in
compliance with the Quality Management Plan & authorize their release for medical devices .
Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical
Device Regulation (European Union Regulation), Quality system regulation (US FDA) .
Assessment of completeness of Design history file and Device master records . Participate i
n reviews as per QMS, external and internal audits Experienced in: . Product risk management
& non-product software validation processes for medical devices .
Key Skills :
Company Profile
imited is a Private incorporated on 03 March 2004. It is classified
as Non-govt company and is registered at Registrar of Companies,
Pune. Its authorized share capital is Rs. 42,500,000 and its paid up
capital is Rs. 42,500,000. It is inolved in Manufacture of structural
metal products, tanks, reservoirs and steam generators
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