Quality Systems Manager – Medical Device Manufacturing

The Quality Systems Manager will lead, maintain, and continuously improve the Quality Management System (QMS) in alignment with ISO 13485, 21 CFR Part 820, and global medical device regulatory expectations. This role serves as the site’s primary owner of QMS compliance, internal and external audits, and regulatory readiness to ensure operations meet the highest standards of safety and quality. The position involves driving ISO 13485 certification, managing FDA Establishment Registration, and overseeing core QMS processes including document control, CAPA, and risk management.