Prajakta Jobs
Location
Pune | India
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 .
Quality Engineer,Purchase Engineer,Purchase Order
Designation: Quality Engineer
Vacancies: 1
Experience: 0 - 3.0 Year(s)
Job tags
Salary
Rs 1 - 3 lakhs p.a.
