QA/RA Engineer – Medical Devices

EMTensor GmbH; Bengaluru; Hybrid; INR 1,500,000 - 2,800,000; Full time

Job summary

EMTensor GmbH is a Vienna-based medical technology company developing a new generation of brain imaging. We seek a hands-on QA/RA professional to implement our Quality Management System and drive regulatory documentation in close collaboration with engineering partners in Vienna and Bangalore.

You will turn the regulatory roadmap into concrete processes, SOPs, and records, and support internal audits and Notified Body certification efforts while maintaining DHF and design controls for Class IIb

Qualifications

• 3–5 years hands-on QA/RA experience with Class IIb medical devices or SaMD.
• Practical experience implementing ISO 13485 processes.
• Solid working knowledge of EU MDR and ISO 14971.
• Experience with design controls, DHF and technical documentation.
• An engineering or natural science degree (e.g. electrical, biomedical, physics).
• A structured, detail-oriented and self-driven way of working.
• Fluent English

Responsibilities

• QMS Implementation (ISO 13485 / EU MDR).
• 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: Maintain DHF and the traceability matrix.
• Risk Management (ISO 14971): maintain risk file with engineering team.
• Supplier and Partner Management: qualify suppliers and collect documentation.
• Testing and Standards: coordinate IEC 60601 testing prep and evidence collection.
• Team Enablement: train colleagues on QMS processes

Skills

QA/RA

ISO 13485

EU MDR

ISO 14971

Design controls

DHF

Regulatory affairs

Medical devices

English

Education

Engineering degree

Natural science degree

Job description

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 fast 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 workshops (FMEA, hazard analysis) and track risk controls through to verification

Supplier and Partner Management

• Qualify and evaluate suppliers and development partners
• Draft quality agreements and collect the required documentation from partners
• Make sure partner deliverables meet our QMS and documentation requirements

Testing and Standards

• Coordinate preparation for IEC 60601-1 and IEC 60601-1-2 (EMC) testing with accredited test labs
• Collect the evidence needed to demonstrate conformity with applicable standards (IEC 62304, IEC 62366-1, ISO 10993)

Team Enablement

• Train colleagues on QMS processes and make compliance practical for a small R&D team

Requirements

• 3-5 years of hands‑on QA/RA experience with Class IIb medical devices or Software as a Medical Device (SaMD)
• Practical experience implementing ISO 13485 processes
• Solid working knowledge of EU MDR and ISO 14971
• Experience with design controls, DHF and technical documentation
• An engineering or natural science degree (e.g. electrical, biomedical, physics)
• A structured, detail-oriented and self-driven way of working
• Comfort in an early‑stage environment where processes are being built
• Fluent English

Nice to Have

• Experience with IEC 60601 test campaigns
• Knowledge of IEC 62304, IEC 62366-1, ISO 10993, ISO 14155
• Experience with a Notified Body audit under MDR
• Familiarity with FDA QMSR (21 CFR 820)
• ISO 13485 internal auditor certification