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Company Description
Client : Leading global IT services firm
• Support R&D, Manufacturing Department to ensure compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices
DUTIES & RESPONSIBILITIES:
• Experience in setting up Quality Management system and understand ISO 13485/14971/IEC 62304 / QSR requirements.
• Support documentation for CAPA analysis / Closure, Change Management & related QA activities.
• Ability to Perform Gap Assessment of QMS / Includes forms with respect to the following requirements.
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