Senior Quality Specialist
Il y a 4 mois
Descriptif du poste
Notre client est une start-up innovante de près de 100 personnes, opérant dans le secteur de la santé avec un focus sur le développement de logiciels d'intelligence artificielle destinés à assister les chirurgiens. L'entreprise recrute aujourd'hui un Quality Assurance Specialist expérimenté.
**Missions**:
- Assurer la conformité du système de management de la qualité aux normes et réglementations en vigueur, en améliorant continuellement le SMQ.
- Analyser les indicateurs de performance clés pour élaborer des plans d'amélioration et prendre en charge la validation des systèmes informatiques.
- Piloter efficacement la gestion des CAPA (actions correctives et préventives), en assurant l'identification des causes, la mise en œuvre des solutions, et le suivi de leur efficacité.
- S'impliquer dans la gestion des réclamations clients et des non-conformités, soutenir les équipes de R&D et de production, et collaborer aux audits.
- Apporter un soutien interfonctionnel aux départements des affaires cliniques et réglementaires, optimisant la collaboration et l'efficacité opérationnelle.
Profil recherché
**Profil recherché**:
- Titulaire d'un master en sciences de la vie ou en ingénierie, justifiant d'au moins trois années d'expérience pertinente dans un rôle d'assurance qualité au sein d'une entreprise de dispositifs médicaux
- Expertise confirmée avec les réglementations MDR 2017/745 et 21 CFR, ainsi qu'une maîtrise des normes ISO 13485, ISO 14971, IEC 62366, IEC 62304, et IEC 60601.
- Expérience avec la gestion électronique des documents et des systèmes de gestion de la qualité électroniques, compétences en validations informatiques, et participation à des audits internationaux.
- Capacités de communication et de leadership avérées, autonomie, précision, et un intérêt prononcé pour le domaine scientifique.
Si vous souhaitez intégrer une équipe dynamique dans une start-up innovante en santé en fort développement à l'international, alors contactez-nous.
Compétences attendues
- LANGUESAnglais
SAVOIR-ÊTRE
Autonomie
Capacité de communication
**Voir plus**
SAVOIR-FAIRE
Assurance qualité
Dispositif médical
**Voir plus**
Entreprise
- Axeme est devenu le partenaire privilégié en recrutement des entreprises dans le domaine de la santé.
- Autres offres de l'entreprise**Personne en charge du recrutement**
CHRISTINE HORVAIS - _consultante_
Salaire
40 - 52 k€ brut annuel
Prise de poste
Dès que possible
Expérience
Minimum 3 ans
Métier
Assureur qualité
Statut du poste
Cadre du secteur privé
Zone de déplacement
Pas de déplacement
Secteur d’activité du poste
PROGRAMMATION INFORMATIQUE
Télétravail
Ponctuel autorisé
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