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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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, 2811 views)

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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
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As a QA manager working for a medical 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 a Lead Auditor for all standards listed above and assist in training organizations to implement all systems. I have more than 7 years of work experience in the medical device sector.

If you need more details, you can contact me at 09650273128.

Regards,
Vareena

From India, New Delhi
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