About Us

EMTensor is a Vienna-based medical technology company developing a new generation of brain imaging. Our electromagnetic tomography system uses safe, low-power electromagnetic fields to image the brain non-invasively, with the goal of supporting rapid diagnosis of stroke and traumatic brain injury, conditions where every minute counts.

Behind the technology are decades of research and a growing international patent portfolio. Today, a multidisciplinary team of engineers and scientists in Vienna and Bangalore, together with specialized development partners, is turning this technology into a certified Class IIb medical device. Joining us now means helping to bring a genuinely new imaging modality from the lab to the clinic.

Your Role

You will be responsible for the hands-on implementation of our Quality Management System and technical documentation. Working closely with our engineering team, development partners and external regulatory experts, you will turn the regulatory roadmap into concrete processes, documents and records.

Responsibilities

QMS Implementation (ISO 13485 / EU MDR)





• Implement QMS processes according to the regulatory roadmap
• Write and maintain SOPs, work instructions, templates and forms
• Set up and run document control, change control and records management
• Handle nonconformances and CAPAs, and maintain training records
• Prepare for and support internal audits and the Notified Body certification audit

Design Controls and Technical Documentation

• Set up and maintain the Design History File and the technical documentation according to MDR Annex II/III
• Organize and document design reviews: prepare agendas, collect inputs, track action items
• Maintain design inputs and outputs and the traceability matrix
• Coordinate verification and validation activities and keep their documentation up to date

Risk Management (ISO 14971)

• Maintain the risk management file together with the engineering team
• Facilitate risk analysis works

📌 QA/RA Engineer – Medical Devices (Bengaluru)
🏢 EMTensor
📍 Bengaluru