Quality Affairs Lead

The Quality Affairs Lead exists to build and own a lean, scalable Quality Management System that enables Adraxe to transition from early clinical success into full product development and commercialization of its Class III implantable neurostimulation system. This role is critical to ensuring design control rigor, DHF integrity, and regulatory readiness for IDE and eventual PMA, while effectively overseeing external partners and maintaining compliance without slowing execution. The impact is company-wide—de-risking the regulatory pathway, accelerating development timelines, and ensuring product safety and quality—directly supporting Adraxe’s mission to deliver breakthrough, minimally invasive neuromodulation therapies to patients. Success in the first 6–12 months looks like establishing a phase-appropriate QMS, achieving audit-ready design controls and risk management processes, supporting a strong IDE submission, and building the foundation for scalable quality operations and team growth.