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.

Support creation and management of labeled medical image datasets for AI algorithms. Collaborate with software, ML, systems engineers and clinical partners to develop data used for automated cardiovascular image analysis. Work on-site in Sudbury, MA.

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