Senior Quality Design Assurance Engineer

3 weeks ago

Montreal, Canada Boston Scientific Full time

Additional Locations: Canada-QC-Montreal

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role

The ideal Senior Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative cardiovascular products. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

 

Your responsibilities will include:

  • Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
  • Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
  • Provide quality and compliance input for post market product sustaining activities, such as design changes, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
  • Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Builds quality into all aspects of work by maintaining compliance to all quality requirements.
  • Support internal and external regulatory audits as required.
  • Other duties as necessary or required by the organization.

 

Required qualifications:

  • Bachelor’s degree in mechanical, electrical, or biomedical engineering, or equivalent.
  • 7+ years of work experience relating to quality assurance in a highly regulated industry.
  • Medical device experience
  • Competent with use of Microsoft Office Suite

 

Preferred Qualifications

  • Focus on detailed work with emphasis on accuracy and completeness
  • Excellent organizational and planning skills; drives for results
  • Strong communication (oral and written) and presentation skills
  • High energy problem solver capable of driving items to closure
  • Ability to collaborate and work on a global team

 

 

À propos du poste

L’ingénieur principal en assurance de la qualité de la conception idéal exerce son leadership dans le cadre de projets de développement de nouveaux produits et de projets de soutien pour nos produits cardiovasculaires novateurs. En outre, il développe, établit et assure la mise en œuvre de méthodologies, de systèmes et de pratiques d’ingénierie appliqués à l’assurance de la qualité qui répondent aux exigences de BSC, des clients et des autorités de réglementation.

 

Responsabilités

  • Comprendre les contrôles de conception, la gestion des risques et la facilité d’utilisation des dispositifs médicaux.
  • Fournir des informations sur la qualité et la conformité aux équipes responsables des projets en ce qui concerne les décisions à prendre et les produits livrables (c’est-à-dire l’analyse des changements relatifs à la conception, les données d’entrée de la conception, les données de sortie de la conception, les méthodes d’essai, les revues de la conception, la vérification et la validation de la conception, les essais de facilité d’utilisation, la validation des logiciels, la validation des processus et l’étiquetage).
  • Fournir des informations sur la qualité et la conformité pour les activités de soutien des produits après leur mise sur le marché, telles que les modifications de la conception, les événements de non-conformité, les besoins d’information prioritaires concernant les actions correctives et préventives, les évaluations des signaux sur le terrain et les actions sur le terrain.
  • Appliquer des compétences techniques, y compris des méthodologies éprouvées et systématiques de résolution des problèmes pour identifier, hiérarchiser, communiquer et résoudre les problèmes de qualité.
  • Collaborer au sein d’une équipe afin d’identifier et de mettre en œuvre des contrôles efficaces pour soutenir le développement ou la maintenance des produits afin de répondre aux exigences internes et externes.
  • Intégrer la qualité dans tous les aspects du travail en maintenant la conformité à toutes les exigences de qualité.
  • Soutenir les audits réglementaires internes et externes, le cas échéant.
  • Exécuter d’autres tâches requises ou exigées par la société.

 

Compétences requises

  • Baccalauréat en génie mécanique, électrique ou biomédical dans un domaine ou équivalent
  • Plus de 7 ans d’expérience professionnelle en matière d’assurance de la qualité dans un secteur hautement réglementé
  • Expérience dans le domaine des dispositifs médicaux
  • Maîtrise de la suite d’applications Microsoft Office

 

Compétences souhaitées

  • Capacité à se concentrer pour effectuer un travail minutieux en mettant l’accent sur l’exactitude et l’exhaustivité
  • Excellentes capacités en matière d’organisation et de planification; volonté d’obtenir des résultats
  • Solides compétences en matière de communications (orales et écrites) et de présentation
  • Excellente capacité à résoudre les problèmes et à mener les dossiers à terme
  • Capacité à collaborer et à travailler au sein d’une équipe internationale

 

Requisition ID: 594178

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

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