Urgent Job Opening As a Quality Engineer

Quality Engineer

1 Nos.
48798
Full Time
Job-93
0 To 3.0 Year(s)
1.00 LPA TO 3.00 LPA
Engg Design / R&D / Product Mgt
Auto/Auto Ancillary
B.Tech/B.E. - Mechanical; Diploma - Mechanical
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 .

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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