Claims Quality Assurance Officer

Company Details: Our client is a Leading Medical Device Company Designation: Quality Assurance Manager Job Location: Sanand GIDC, Gujarat, India Role Overview We are looking for an experienced Quality Assurance Manager to lead and strengthen our Quality Management System (QMS) for medical devices. The ideal candidate will ensure compliance with ISO 13485, EU MDR, FDA QSR/QMSR, and other applicable regulatory requirements while driving quality excellence across manufacturing operations. Key Responsibilities Lead and maintain the Quality Management System (QMS) in compliance with ISO 13485, EU MDR, FDA QSR/QMSR, and other applicable regulations. Manage quality documentation, SOPs, document control, change control, and QMS performance metrics. Plan, conduct, and coordinate internal, supplier, certification, and regulatory audits, ensuring timely CAPA closure. Drive CAPA, Non-Conformance (NCR), deviation management, root cause analysis, and continuous improvement initiatives. Oversee risk ...