Senior QA Engineer Medical Devices Compliance

Mizuho OSI is seeking a QA Engineer to lead quality assurance activities and ensure compliance with FDA QMSR, ISO 13485, and EU MDR for capital equipment and accessories. The role supports manufacturing, design validation, and continuous improvement initiatives across cross-functional teams. Responsibilities include audits, CAPA management, labeling collaboration, documentation for sterilization processes, and maintaining regulatory readiness.