Company Description Company Description Client : Leading global IT services firm Job Description • 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.