Immediate Interview -QARA

• 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.