Quality Assurance Specialist
il y a 2 semaines
Role: QA/RA Medical Devices Specialist Location: Liege Salary : €55,000 + Company car Industry : MedTech Role type: Hybrid About the job As a QA & RA Device Specialist, you are responsible for activities related to the regulatory compliance of equipment, software, and medical devices, as well as for monitoring the quality records of these products (in particular regulatory contacts with subcontracted medical device manufacturers). You contribute to the development of future company products, the maintenance of existing products, and support the continuous improvement of products and processes. You interact and collaborate with various teams to collect and validate the accuracy of working data. You play a key role in promoting a regulatory and compliance culture, both internally and externally. Responsibilities Stay up to date with regulatory requirements, assess potential medium- and long-term risks and impacts, and communicate them to company stakeholders Participate in identifying applicable regulatory requirements for the different markets targeted by the commercial departments Support the integration of regulatory and normative requirements (IEC 60601, ISO 62304, etc.) into product development processes and educate teams on product-related requirements Provide regulatory guidance to establish the most appropriate regulatory strategy and integrate medical device and software requirements into the quality system Contribute to the preparation of regulatory dossiers (CE marking, 510(k), etc.), manage their lifecycle, and maintain these authorizations Ensure that regulatory files at subcontractors are properly updated Participate in the submission of regulatory dossiers to competent authorities and notified bodies Take part in company and product registrations in regulatory databases (EUDAMED, GUDID, FAMHP/AFMPS) Ensure follow-up and management of quality events (deviations, change control, CAPA) related to operational quality processes and/or medical devices Monitor vigilance and post-market surveillance events (medical device vigilance) Participate in evaluating regulatory impact during change control and deviation management, and collaborate with other departments to define the most appropriate communication strategy Profile Master’s degree in a technical field (mechanical, electromechanical, biomedical engineering, etc.) or equivalent experience Minimum 3 years of experience in a similar role Knowledge of ISO 13485, ISO 14971, ISO 62304 standards Knowledge of GAMP-5 ; IEC 60601 is an asset Knowledge of medical device and machinery regulations Fluent in English Proficient in Microsoft Office suite
-
Quality Assurance Specialist
il y a 4 semaines
Liège, Belgique Vivid Resourcing Temps pleinRole: QA/RA Medical Devices SpecialistLocation: LiegeSalary: €55,000 + Company carIndustry: MedTechRole type: HybridAbout the jobAs a QA & RA Device Specialist, you are responsible for activities related to the regulatory compliance of equipment, software, and medical devices, as well as for monitoring the quality records of these products (in particular...
-
Quality Assurance Specialist
il y a 2 semaines
Liège, Belgique Vivid Resourcing Temps pleinRole: QA/RA Medical Devices SpecialistLocation: LiegeSalary: €55,000 + Company carIndustry: MedTechRole type: HybridAbout the jobAs a QA & RA Device Specialist, you are responsible for activities related to the regulatory compliance of equipment, software, and medical devices, as well as for monitoring the quality records of these products (in particular...
-
Quality Assurance Specialist
il y a 2 semaines
Liège, Belgique Vivid Resourcing Temps pleinRole: QA/RA Medical Devices SpecialistLocation: LiegeSalary: €55,000 + Company carIndustry: MedTechRole type: HybridAbout the jobAs a QA & RA Device Specialist, you are responsible for activities related to the regulatory compliance of equipment, software, and medical devices, as well as for monitoring the quality records of these products (in particular...
-
Quality Control Officer
il y a 2 semaines
Liège, Belgique S&you Belgium Temps pleinLe groupe RH français Synergie compte 600 bureaux dans 15 pays différents . S&You est une division spécialisée dans le recrutement, la sélection et la recherche par approche directe de profils cadres ou expérimentés. Notre client est l’un des fabricants principaux sur le marché mondial de films plastiques de première qualité, destinés aux...
-
Quality Control Officer
il y a 2 semaines
Liège, Belgique S&you Belgium Temps pleinLe groupe RH français Synergie compte 600 bureaux dans 15 pays différents . S&You est une division spécialisée dans le recrutement, la sélection et la recherche par approche directe de profils cadres ou expérimentés.Notre client est l’un des fabricants principaux sur le marché mondial de films plastiques de première qualité, destinés aux...
-
Quality Control Officer
il y a 2 semaines
Liège, Belgique S&you Belgium Temps pleinLe groupe RH français Synergie compte 600 bureaux dans 15 pays différents . S&You est une division spécialisée dans le recrutement, la sélection et la recherche par approche directe de profils cadres ou expérimentés.Notre client est l'un des fabricants principaux sur le marché mondial de films plastiques de première qualité, destinés aux marchés...
-
Strategic Head of Supply Chain, Procurement
il y a 5 jours
Liège, Belgique GTS Group Ltd Temps pleinA leading electronics design and manufacturing specialist based in Belgium is seeking a Head of Supply Chain, Procurement & Quality. This senior leadership role involves overseeing sourcing strategies and ensuring operational efficiency while leading multi-disciplinary teams. Ideal candidates will have substantial experience in electronics or EMS...
-
Quality Engineer
il y a 2 semaines
Liège, Belgique Randstad Belgium Temps pleinDevenez notre prochain QA Engineer ! Vous ne vous contentez pas de vérifier la conformité, vous sculptez la fiabilité des produits. En tant que pilier central des projets, vous transformez les indicateurs techniques (OTD, OCD) en garanties de succès. Votre mission : En tant que QA Engineer produit/projet, vous contribuez à la gestion de la qualité...
-
Talent Acquisiton Specialist
il y a 1 semaine
Liège, Belgique CareerWallet Temps pleinActif depuis plus de 30 ans dans le monde du recrutement, Profile Group a développé ses activités partout en Belgique au travers ses bureaux de Bruxelles, d'Anvers et depuis 2008, de Liège. La clé de notre succès ? Bien plus que des simples relations commerciales, nous construisons de vrais partenariats longue durée avec nos clients que nous...
-
Quality Engineer
il y a 2 semaines
Liège, Belgique Randstad Belgium Temps pleinDevenez notre prochain QA Engineer ! Vous ne vous contentez pas de vérifier la conformité, vous sculptez la fiabilité des produits. En tant que pilier central des projets, vous transformez les indicateurs techniques (OTD, OCD) en garanties de succès.Votre mission : En tant que QA Engineer produit/projet, vous contribuez à la gestion de la qualité...
