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 in reviews as per QMS, external and internal audits Experienced in: . Product r
isk management & non-product software validation processes for medical devices . Creation and maintenance of technical
file/summary technical documentation (STED) . Medical device development (including SW) and Software engineering
best practices . Agile methods / TIR45 Knowledge on: . Compliant to ISO 9001, 13485, ISO 14971, IEC 62304 &
IEC 82304, MDR, QSR within projects .
Key Skills :
Company Profile
The Company, founded in 1959
as a pioneer industry,
was one of the first ---
manufacturing facilities India
to employ automati machinery.
The plant specializes
in high precision ---s manufactured
for a wide spectrum of
rigorous industrial applications.
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