Quality Specialist

The Quality Specialist supports the development and maintenance of the Quality Management System (QMS) to ensure compliance with FDA 21 CFR 820 and ISO 13485 standards. The role involves leading CAPA activities, mentoring regional teams on QMS processes, and facilitating nonconformance coach meetings to drive continuous improvement. The position requires analyzing quality metrics, maintaining nonconformance records, and supporting internal and external audits to ensure regulatory compliance.