Quality Management Engineer (f/m/x) 2-Year Fixed-Term Contract
Core
Ensure safety, effectiveness, reliability, and regulatory compliance of innovative medical devices throughout their lifecycle.
Role type
Quality Management Engineer (Medical Devices)
Builds
Next-generation medical technologies for ophthalmology and microsurgery
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (ISO 14971), Quality Management System (QMS) maintenance, Audit planning and execution, CAPA, 8D Problem Solving, Root Cause Analysis, Statistical analysis
Preferred skills
Experience in medical device industry (ISO 13485, MDSAP), Multidisciplinary collaboration
Technologies
ISO 14971, ISO 13485, MDSAP, FMEA
Responsibilities
Ensure process and regulatory compliance with established product development processes, Own and maintain product risk management activities, Participate in and facilitate risk assessments including Design and Process FMEAs, Monitor risk controls and evaluate their effectiveness, Plan, conduct, and document internal and external audits, Support the systematic maintenance and continuous improvement of the Quality Management System
Seniority
Mid-level, hands-on IC
