Senior Quality Design Assurance Engineer/ingénieur principal en assurance de la qualité
Job in
Montreal, Montréal, Province de Québec, Canada
Listing for:
Boston Scientific
Full Time
position
Listed on 2026-01-01
Job specializations:
-
Engineering
Quality Engineering, QA Specialist / Manager
-
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below
Position: Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité
Location: MontrealAdditional Location(s): 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 experienceCompetent with use of Microsoft Office SuitePreferred Qualifications
Focus on detailed work with emphasis on accuracy and completenessExcellent organizational and planning skills; drives for resultsStrong communication (oral and written) and presentation skillsHigh energy problem solver capable of driving items to closureAbility to collaborate and work on a global teamÀ 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…
Position Requirements
10+ Years
work experience
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