Director of Quality Assurance
Core
Lead the Quality function for a non-invasive neuromonitoring medical device, covering QMS, design quality assurance, and supplier quality to ensure compliance and readiness for market release.
Role type
Director of Quality Assurance (Medical Devices)
Builds
Non-invasive neuromonitoring device (electronics, optics, software)
Domain
Medical Devices / Neurotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485, FDA QMSR (21 CFR Part 820), Design Controls, ISO 14971 Risk Management, CAPA, Validation, Supplier Quality, Audit Leadership, Software Quality (IEC 62304), Cybersecurity, Clinical Data Quality
Preferred skills
ASQ CQE/CQA/CMQ-OE, RAC, Lead Auditor certification, SaMD/AI-ML guidance experience, Human Factors, Complex integrated product background
Technologies
FDA QMSR, ISO 13485, IEC 62304, IEC 62366, EU MDR, UK CA
Responsibilities
Lead and develop the Quality team; Ensure QMS compliance with FDA QMSR and ISO 13485; Lead annual ISO 13485 audits and FDA inspection readiness; Oversee design controls, risk management, and software quality processes; Manage supplier qualification and manufacturing quality; Establish post-market surveillance and complaint handling processes; Provide oversight on cybersecurity and clinical evaluation.
Seniority
Director, hands-on leadership