Job Description

This role is for someone who wants genuine ownership of a hybrid hardware/software QMS and wants to be close to the regulatory and engineering core of an AI SaMD company. You'll own and operate our Quality Management System across multiple devices (SaMD + hardware) and be directly responsible for FDA/ISO-aligned documentation, design controls, supplier quality, clinical-quality support, and software validation oversight. You'll work directly with the COO/CPO, CTO, and our Director of Clinical Research.