QA Officer - Promising Medical Software

☞ NonStop Consulting

Vue: 145

Jour de mise à jour: 16-11-2025

Localisation: Ghent East Flanders

Catégorie: IT - Logiciel IT - Matériel / Réseaux Informatique Direction

Industrie:

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le contenu du travail

If you would like to work for a medical device start-up company, then I have an interesting proposal for you as QA Officer. This company develops ground-breaking medical software that will improve the situation for as well doctors as patients so you can play a part in this and build good quality processes.
This is a new role to support the RA/QA Manager but because it is a small company structure with less hierarchy you will be able to and even be encouraged to give input and help to improve the QMS. It is a more dynamic environment where you will see faster results and where you will see your value which will make it more interesting.

Responsibilities:
Support the continues improvement of the Quality Management System (QMS) and write new SOP’s
Act as responsible person for Computerized System Validation (CSV)
Prepare and support in internal audits
Follow up on non-conformities and CAPA’s and support in compilation of Design History File
Handle complaints
Perform root cause and risk analysis
Train others on the QMS processes

Requirements:
Master Degree in Life Sciences or Engineering or similar by experience
First years of experience in Quality Assurance for the medical devices, diagnostics or pharmaceutical industry
Experience with CSV
Knowledge of ISO 13485 and MDR is a plus
Knowledge of IEC 62304 standard or affinity with software or IT is preferred
Fluent level of English
If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.
NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.
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Date limite: 31-12-2025

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