Teams at Gentuity, LLC

Manage and maintain the medical device Quality Management System to meet FDA, ISO, and regional requirements. Oversee document control, CAPA, complaints, supplier management, audits, training, quality metrics, management reviews, and lead regulatory audits. Coach direct reports, drive QMS improvements, and manage related projects.

Develop and manage technical specifications for medical imaging hardware. Conduct compliance testing, support existing products, and lead cross-functional teams.

The role involves developing and leading test strategies for medical device verification, managing testing processes, ensuring compliance with regulatory standards, and overseeing lab operations and team mentoring.