Quality Control Assurance For Medical Device Company

Dear Seniors,

Kindly help me to understand the role and responsibility of Quality Control Assurance for a Medical Device Company.

Hi,

Please find attached the responsibilities of a QA Incharge in a medical device company. A new joiner in this position is provided with this statement to understand their role and responsibilities.

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]

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