The Quality Assurance Manager will have strong hands-on experience with ISO 13485, FDA Quality Management System Regulation (QMSR), EU MDR, MDSAP, CAPA, internal and external auditing, supplier quality, complaint handling, and document/change control .This role serves as a key Quality representative during regulatory and certification audits and works closely with Regulatory Affairs, Engineering, Operations, Supply Chain, and executive leadership to maintain inspection readiness and drive a strong culture of quality throughout the organization. Key competencies include strong auditing capability, sound quality judgment, attention to detail, effective root cause analysis, technical writing, data-driven decision-making, leadership, and the ability to communicate quality and compliance expectations across all levels of the organization.