About Mentis Care
Mentis Care is building AI-powered neuro-monitoring technology to transform epilepsy care. We combine wearable EEG, advanced AI models and a cloud-based clinical platform to give patients and clinicians a continuous, real-world view of neurological health. We are backed by global pharmaceutical partners.
The role
You’ll run the quality management system (QMS) that lets Mentis Care design, release and maintain medical devices that pass FDA and MDSAP audits. Our products include a patient app, a wearable EEG device made by a contract manufacturer, and AI software, so the QMS has to cover software, AI and hardware. You’ll work closely with R&D, the AI team and our contract manufacturer. This role has a target start of Q2 2027.
What you’ll do
- Maintain the QMS to ISO 13485 and the FDA Quality Management System Regulation (QMSR, 21 CFR 820), using our electronic QMS (eQMS).
- Own document control, training records, corrective and preventive action (CAPA), complaint handling and nonconformance.
- Support design controls and risk management (ISO 14971) with R&D and the AI team, including the software lifecycle (IEC 62304).
- Manage supplier quality, including the contract manufacturer of our wearable EEG device: quality agreement, audits and incoming inspection.
- Plan and run internal audits and management reviews.
- Prepare for and host MDSAP and other external audits.
What you bring
- 8+ years in medical device quality assurance, including 3+ years running a QMS.
- Hands-on ISO 13485 and 21 CFR 820 experience.
- Experience with design controls and supplier audits.
- Experience with software or software as a medical device (SaMD).
Nice to have
- ISO 13485 lead auditor training.
- MDSAP audit experience.
- Startup or small-team experience.
Why join us
- Build quality into a neurological technology platform at a pivotal stage of growth.
- Work across wearable EEG hardware, AI software and patient apps.
- Join a mission-driven company backed by global pharmaceutical partners.