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Quality Manager - Medtech
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Quality Manager - Medtech
- Neuchâtel, Neuchâtel, Switzerland
- Neuchâtel, Neuchâtel, Switzerland
Über
Mandatés par un de nos clients, nous recherchons un/e :
Quality Manager - Medtech
- Formation technique supérieure (ES/HES), complétée par une formation en management de la qualité
- Expérience confirmée en assurance qualité dans un environnement de production Medtech
- Expérience en management d'équipe et intérêt marqué pour les sujets techniques
- Bonnes connaissances ISO 13485, FDA 21 CFR Part 820, CAPA, audits et change management
- Expérience en Regulatory Affairs = un atout
- Formation ou bonnes connaissances en Lean Management
- Communication sûre avec les départements internes, clients et fournisseurs
- Bonne maîtrise de MS Office, expérience CAQ/ERP
- Langues : français et allemand = courant ; anglais = bon niveau
Les avantages :
- Un poste clé avec responsabilité globale qualité sur deux sites
- Un environnement Medtech international, exigeant et orienté amélioration continue
- Une culture ouverte, des décisions rapides et une philosophie open-door
- Des possibilités de développement individuel
- 6 semaines de vacances, avantages sociaux attractifs, événements d'équipe et primes de fidélité
- Assurer la fonction de Quality Management Representative pour le QMS certifié et harmonisé sur 2 sites
- Manager l'équipe QA des deux sites et garantir la responsabilité globale des activités qualité locales
- Maintenir et améliorer le QMS selon ISO 13485, FDA 21 CFR Part 820 et réglementations applicables
- Piloter les audits internes, clients et organismes notifiés, de la préparation au suivi des actions
- Être l'interlocuteur principal des clients, autorités, organismes notifiés et partenaires sur les sujets qualité
- Superviser les processus QA clés : réclamations, CAPA, change management et audit management
- Suivre les KPI qualité, reporter la performance QMS à la direction / Global QA et conduire l'amélioration continue
- Gérer les ressources QA, le leadership d'équipe et le budget
- Soutenir les activités Regulatory Affairs
Sprachkenntnisse
- French
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