Lead Test / QA Lead defining and piloting testing strategies for complex programs at Tech Riders, a consulting firm based in Paris.
About the role
- Join a leading firm as an experienced QARA Consultant focusing on diverse medical device projects. Engage with varied clients while managing regulatory reporting and compliance in a collaborative team.
Responsibilities
- La rédaction et la mise à jour de dossiers techniques sous MDR (2017/745)
- La définition et le pilotage de stratégies réglementaires
- La gestion des risques selon l’ISO 14971
- La mise en conformité et l’amélioration de SMQ ISO 13485
- Les interactions avec les Organismes Notifiés
- L’accompagnement des clients en phase de développement ou de transition réglementaire
- Après une phase d’intégration, vous gérez 2 à 3 projets en parallèle en toute autonomie.
Requirements
- Bac+5 scientifique (ingénieur, biomédical…)
- Minimum 5 ans d’expérience en QARA dispositifs médicaux
- Maîtrise opérationnelle du MDR
- Expérience d’interaction avec un Organisme Notifié
- Anglais courant (écrit indispensable C1)
- Seront appréciés : Expérience FDA / 510(k)
- Dispositifs classe III
- Logiciels médicaux (IEC 62304)
- Connaissances en cybersécurité / IA
Benefits
- Environnement coopératif avec possibilité d’intégration au capital après un an
- Forte autonomie et diversité des projets
- Travail en équipe experte et collaborative
- Peu de déplacements (1 à 2 par mois)
- 2 jours de télétravail par semaine
Job title
Job type
Experience level
Salary
Degree requirement
No Education Requirement
Location requirements
Senior Software Tester at Emerson testing the DeltaV MES platform software. Collaborating with developers and participating in agile activities.
QA Analyst handling analytical testing and quality assurance for Baldwin Richardson Foods. Supporting production compliance with food safety and quality standards in a manufacturing setting.
QA Technician ensuring stringent quality standards and regulatory compliance at Vibrant Ingredients. Conduct inspections, tests, and support continuous improvement for product reliability and customer satisfaction.
Test Automation / QA Engineer responsible for ensuring high quality in mobile apps and cloud services. Working with both manual and automated testing for various workflows and integrations.
Quality Controller in automotive sector focusing on inspections and rework of components at Vollmann Group. Ensuring quality standards and compliance with technical specifications at Crimmitschau site.
Specialist Quality Engineering role focusing on Python Automation. Responsible for coordinating test efforts and enhancing automation scripts with a strong emphasis on collaboration and problem - solving.
Quality Engineer developing standards and methods for inspecting aerospace products in Camden, Arkansas. Conducting analysis on nonconformities and leading PFMEA activities.
Developing innovative IVD tests with LC - MS technology at Roche. Focused on automated methods for sample preparation and analytics.
Quality Assurance Analyst II ensuring quality in digital applications for TheIncLab. Independently plans and executes testing for assigned features, collaborating with development and product teams.