Quality Engineer
Job Description:
Responsible for: . Analyzing, collecting data, and providing accurate,
documented information about the status of quality . Verifying the c
orrectness 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 risk management
& non-product software validation processes for medical devices
Key Skills :
Company Profile
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