Quality Systems Specialist

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Do you have experience with MDSAP audits? Can you describe your role in a previous MDSAP audit? *

Have you worked directly with notified bodies for ISO 13485 or FDA audits? What was your involvement? *

How have you managed supplier quality with an overseas contract manufacturer? *

Can you describe your experience with post-market surveillance activities? *

What risk management frameworks (e.g., ISO 14971) have you implemented ? *