Dear Seniors, Kindly help me out to know about the Role & Responsibility of the Quality Control Assurance for Medical Device Company.
From India, Mumbai
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Arc
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Vickybhat
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arc
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Hi, Pls find attached responsibilities of QA Incharge in a medical device company New joinee in this position is handed over this statement to enable him to know his role & responsibilities.
From India, Hyderabad

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File Type: doc Job responsibilities- QA.doc (23.5 KB, 2651 views)

Dear arc,
Thanks, it describes about the resposibility of a quality assurance for devices company. I need a little more details in comprehensive methods are used in QA like, Technical filings, CE mark procedures, Sterlization methods, Filing & Testing, S.O.P & Text Writing for SOP, Infrastructure developement, ISO9001: Procedure for Paper Filing.

From India, Mumbai
For a QA manager working for amedical device company you need to have a thorough knowledge of ISO 13485:2003.WHO GMP,CE as per MDD directive and US FDA guidelines.
I am Lead Auditor for all standards listed above and assit & train organisation in implementing all systems and have more than 7yrs of work experience in medical device sector.
If you need more details you can contact me on 09650273128
Regrads
vareena

From India, New Delhi

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