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Dear Seniors, Kindly help me out to know about the Role & Responsibility of the Quality Control Assurance for Medical Device Company.
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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.

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File Type: doc Job responsibilities- QA.doc (23.5 KB, 2400 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.
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
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