QA/RA Engineer – Medical Devices

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

• 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

• 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

Please send your CV and a short cover letter to Lizaveta.shatalava@emtensor.com.

In your cover letter, please tell us:

• which medical device(s) you have worked on, including the device class and the type of device


• which challenges you faced while implementing or maintaining the QMS or technical documentation, and how you solved them

Diese Anzeige stammt von Indeed. Originalanzeige ansehen ↗