Quality & Regulatory Specialist

4 weeks ago


Montréal, Canada Straumann Group Full time

Chez Straumann Montreal, nous **#repoussonsleslimites** de la dentisterie numérique depuis 2007. Nous croyons que la bonne technologie peut rendre la dentisterie prévisible, agréable et moins stressante autant pour les patients que pour les dentistes.

Lorsqu’on parle de notre vision, on parle souvent de la façon dont nos développeurs et nos ingénieurs travaillent pour mettre en œuvre la prochaine génération de soins dentaires numériques. Notre philosophie va encore plus loin : notre but est de **créer la meilleure expérience client** dans le domaine. Nous valorisons nos employés en leur donnant les moyens de réussir et d'avoir un impact, de remettre en question le statu quo, de mettre en œuvre des changements et de garder une longueur d'avance sur la concurrence.

Basés à Montréal (Canada), avec des bureaux à Berlin, Chemnitz (Allemagne) et Lyon (France), nous faisons partie du groupe Straumann depuis 2017. Nos produits sont distribués par des entreprises dentaires de premier plan dans plus de 70 pays à travers le monde.

Nous **#repoussonsleslimites** tous les jours. Joignez-vous à nous

Veuillez prendre note que le masculin est utilisé afin d'alléger le texte, et ce, sans préjudice pour la forme féminine.

**Responsabilités et tâchesessentielles**:
Développement de produit
- Fournir une expertise qualité, réglementaire et normative aux équipes d'ingénierie afin de répondre aux exigences de conception.
- Exécuter le plan de gestion des risques et travailler avec l'équipe d'ingénierie pour identifier, documenter et contrôler les risques conformément aux normes ISO 14971 et IEC 62304.
- Participer aux revues de conception (Design Reviews) et s'assurer que le produit est développé conformément aux exigences réglementaires, aux exigences du client et tient compte des risques identifiés.
- Participer à la revue des requis de produit.
- S'assurer que les produits sont évalués et testés pour la conformité à tous les codes et normes applicables (CE, CSA, FCC, ISO, UL, etc.).
- S'assurer que les activités de vérification et de validation (V&V) sont conformes aux procédures de contrôle de la conception. Examiner les livrables de V&V et s’assurer que le produit rencontre les requis applicables.
- Participer à l’évaluation et à la résolution des déviations et anomalies identifiés par l’équipe V&V.
- Participer à la définition des exigences de transfert du produit en production.
- Collaborer avec les fonctions d'ingénierie et de production pour garantir la mise en place des requis qualité.
- Contribuer au plan de développement des produits en collaboration avec les directeurs de programme et les chefs de produit (Product Owners) afin de résoudre les problèmes qualité.

Maintien de produits (sustaining)
- S'assurer que les exigences des clients et la conformité réglementaire du produit sont maintenues par l'évaluation des changements de conception et de la réglementation.
- Évaluer les risques tout au long du cycle de vie du produit et tenir à jour le plan de gestion des risques.
- Feedbacks et traitement des plaintes (Effectuer une analyse des données et des tendances des plaintes; Initier et mener des investigations sur les plaintes; Recueillir et présenter les données dans les revues périodiques).
- S'assurer que les mesures correctives répondent à des normes de fiabilité acceptables et que la documentation est conforme aux exigences.
- Mettre à jour le dossier de risque suite à l’analyse des plaintes.
- Communiquer les changements de conception (design) à l'organisme notifié afin de maintenir la certification du produit.
- Autres tâches connexes.

**Prérequis essentiels**:

- Diplôme universitaire en ingénierie électrique/électronique, mécanique, électromécanique ou logicielle;
- 3 ans d'expérience dans une industrie réglementée (par exemple équipements médicaux, produits pharmaceutiques, aérospatial, automobile);
- Maîtrise du français et de l'anglais.

**Notre Offre**:

- Horaires flexibles et congés mobiles
- Le meilleur qui soit : autonomie et travail d'équipe
- Assurance collective
- REER collectif incluant une cotisation de l'employeur
- Fruits, bagels, café et thé offerts gratuitement
- Un environnement de travail dynamique et multiculturel
- Bureaux facilement accessibles en transports en commun, situés au 160 St-Viateur Est, dans le branché Mile-End

et bien d'autres choses Joignez-vous à l'équipe de pointe de l'industrie dentaire **:#JoinStraumann** et travaillez avec nous **:#WeChangeDentistry**
- ________________________________

At Straumann Montreal, we have been **#pushingtheboundaries** of digital dentistry since 2007. We believe that the right technology can make dentistry predictable, enjoyable and less stressful for both patients and dentists.

When we talk about our vision, we often talk about how our developers and engineers are working to implement the next generation of digital dental care. Our philosophy goes even further: our goal is to create the best customer experience in the field. We



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