Stage - Assistant(e) Responsable Qualité
Core
Define action plans to complete the Quality Management System (QMS) in preparation for ISO13485 certification, update the QMS, and ensure regulatory monitoring.
Role type
Quality Management System Assistant (Intern)
Builds
Quality Management System documentation and regulatory compliance for a biotech startup
Domain
Medical Devices / Biotechnology / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485, ISO 14971, ISO 62304, MDR 2017/745, QMS documentation, regulatory monitoring
Preferred skills
English (oral and written), autonomy, attention to detail
Technologies
ISO 13485, ISO 14971, ISO 62304, MDR 2017/745
Responsibilities
Define action plans to complete the QMS for ISO13485 certification, update the QMS, ensure regulatory monitoring, write reports and procedures
Seniority
Intern