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,

Thank you for the information on the responsibilities of a Quality Assurance role in a device company. I am interested in learning more about the comprehensive methods used in Quality Assurance, such as Technical filings, CE mark procedures, sterilization methods, filing and testing, writing Standard Operating Procedures (SOPs) and Text for SOPs, infrastructure development, and ISO9001 procedures for paper filing.

I look forward to gaining deeper insights into these areas. Thank you for your assistance.

Best regards,
[Your Name]

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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