Devices Development Quality Lead
vor 1 Woche
Groupe de conseil international fondé en 2019, Ekkiden anime un écosystème de consultants passionnés et engagés qui mènent des projets de transformation organisationnelle, opérationnelle et technologique dans l'IT/Digital, l'Industrie/R&D et la sustainability, chez les grands comptes et PME, en France, Suisse, Espagne et Allemagne.
Le rôle :Vous serez en charge de la supervision qualité des activités de contrôle de la conception des dispositifs et produits combinés.
Responsabilités :Assurer la conformité des nouveaux développements et la gestion du cycle de vie des dispositifs d'administration de médicaments.
Superviser les activités de conception et de développement, de la définition des données d'entrée au transfert de conception (y compris les activités de validation/vérification).
Examiner et approuver les sections pertinentes de la documentation de contrôle de la conception du dispositif et/ou du dossier de documentation technique, selon les besoins.
Examiner et approuver les protocoles et les rapports des études de vérification et de validation, des transferts de technologie, des études de stabilité, etc.
Examiner et approuver la documentation. S'assurer de la mise en place du dossier d'historique de conception (DHF).
Soutenir les activités de gestion des risques liées aux dispositifs.
S'assurer que les évaluations des risques sont réalisées aux stades appropriés du développement/de la commercialisation et permettent la prise de décision sur les problèmes rencontrés.
Vous avez 3 à 6 ans d'expérience en control design.
Vous avez de l'expérience dans les produits combinés et dans les dispositifs médicaux.
Expérience dans le design control (ISO13485, 21CFR).
Expérience dans le life cycle management.
Compréhension technique / réglementaire, capacité technique.
Gestion documentaire.
Anglais obligatoire.
Nous rejoindre au bon moment pour faire votre place au sein d'une organisation en très forte croissance.
Des missions variées dans un environnement challengeant qui vous permettront d'avoir un réel impact sur la boite.
La possibilité de travailler de façon autonome et d'être force de proposition pour grandir ensemble.
Un parcours de carrière adapté à ta personnalité, aussi bien au niveau du rôle que de la localité.
Une formation exigeante en continu pour libérer tout votre potentiel.
Comment se déroule le processus de recrutement chez Ekkiden ?Chez Ekkiden, nous nous engageons à offrir une expérience positive à chaque candidat.
Premier contact :Notre équipe de recrutement vous contactera pour discuter de vos motivations et attentes.
Entretiens :Vous passerez un ou deux entretiens avec nos business managers, en fonction du poste pour lequel vous postulez.
Rencontre avec le client :Enfin, vous aurez l'opportunité de rencontrer le client.
Bien que ce soit notre processus standard, nous pouvons l'adapter en fonction des circonstances spécifiques.
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