Junior Qa Engineer Jobs in Quebec (NOW HIRING)

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.

French Translation to follow

About the role:  

We have a high-impact opportunity for a Design Quality III to lead design assurance efforts for a critical medical device in the Electrophysiology space. This role requires a self-driven professional capable of independently managing complex technical challenges and driving to solutions across hardware, software, and system domains. They will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness.  

Work Mode: 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our Montreal, QC office at least three days per week.  

Visa Sponsorship: 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. 

Your responsibilities will include:  

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.  
• Independently lead design control activities for the Capital Equipment, including Design & Development planning, risk management, design verification, and validation efforts, with a strong focus on robustness of system design and documentation.  
• Collaborate closely with R&D, regulatory, manufacturing, and clinical teams  to provide expert guidance on design and compliance matters throughout the product lifecycle.  
• Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, software, and system risks, applying advanced risk mitigation strategies to influence robust design decisions  
• Lead root cause investigations and resolution of test failures, CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight.  
• Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and quality processes.  
• Proactively identify gaps and opportunities for continuous improvement in product development processes, tools, and documentation.  
• Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections.  
• Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations, and ability to influence project team towards quality-centric decisions and behaviors 

Required Qualifications  

• Bachelor's degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline.  
• 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.  
• Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and Quality management systems (ISO 13485). 
• Proven ability to independently lead complex product development projects, including software and system quality assurance activities, from inception through completion.  
• Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with a hardware, software and system focus.  
• Strong problem-solving skills with experience leading root cause analysis and CAPA investigations.  
• Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives.  
• Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment.  

Preferred Qualifications  

• Experience mentoring or leading junior engineers in design assurance or software/systems engineering activities.  
• Experience with Capital Equipment 
• Knowledge of software quality standards (IEC 62304) and software/system development principles.  
• Prior experience working on or supporting cardiac mapping systems or similar complex medical device platforms.  
• Strong project management skills and familiarity with agile development methodologies.  

A propos du poste :

Nous avons une occasion a fort impact pour un(e) Specialiste qualite de conception III (Design Quality III) qui dirigera les activites d'assurance qualite de la conception pour un dispositif medical critique dans le domaine de l'electrophysiologie. Ce poste exige un(e) professionnel(le) autonome capable de gerer de facon independante des defis techniques complexes et de piloter des solutions touchant le materiel, les logiciels et les systemes. Cette personne influencera les initiatives strategiques en matiere de qualite, encadrera des ingenieurs juniors et agira comme ressource cle au sein d'equipes multidisciplinaires afin d'assurer la securite des produits, la conformite reglementaire et la robustesse de la conception.

Mode de travail :

Chez Boston Scientific, nous valorisons la collaboration et la synergie. Ce poste suit un modele de travail hybride exigeant une presence au bureau de Montreal (Quebec) au moins trois jours par semaine.

Parrainage de visa :

Boston Scientific n'offrira pas de parrainage ni ne prendra en charge le parrainage d'un visa de travail pour ce poste a l'heure actuelle.

Vos responsabilites comprendront :

• Agir a titre d'autorite technique au sein de la fonction Qualite pour l'integration des systemes, les decisions de conception, la gestion des risques ainsi que le developpement et la validation des logiciels.
• Diriger de maniere autonome les activites de controle de la conception pour les equipements d'immobilisation (Capital Equipment), notamment la planification de la conception et du developpement, la gestion des risques, la verification et la validation de la conception, avec un fort accent sur la robustesse de la conception des systemes et de la documentation.
• Collaborer etroitement avec les equipes de R-D, des affaires reglementaires, de la fabrication et des affaires cliniques afin de fournir une expertise sur les questions de conception et de conformite tout au long du cycle de vie du produit.
• Etre responsable de la creation et du maintien des dossiers complets de gestion des risques (analyse des dangers, AMDE/FMEA), en assurant une couverture robuste des risques lies au materiel, aux logiciels et aux systemes, tout en appliquant des strategies avancees d'attenuation des risques afin d'influencer des decisions de conception robustes.
• Diriger les enquetes sur les causes fondamentales et la resolution des echecs de tests, des CAPA, des NCEP et des plaintes, en mettant en uvre des actions correctives et preventives avec un minimum de supervision.
• Fournir du mentorat et des conseils aux ingenieurs juniors concernant les meilleures pratiques en assurance de la conception, les exigences reglementaires et les processus qualite.
• Identifier de maniere proactive les lacunes et les occasions d'amelioration continue des processus de developpement de produits, des outils et de la documentation.
• Agir comme principal point de contact pour l'assurance de la conception lors des audits internes et externes ainsi que des inspections reglementaires.
• Gerer efficacement plusieurs priorites et projets de facon autonome, demontrer une solide capacite de prise de decision dans des situations ambigues et influencer les equipes de projet vers des decisions et des comportements axes sur la qualite.

Qualifications requises

• Baccalaureat en genie mecanique, genie electrique, genie logiciel, genie biomedical ou dans une discipline technique connexe.
• Plus de 6 ans d'experience en assurance qualite, assurance de la conception, qualite logicielle ou dans des fonctions connexes au sein de l'industrie des dispositifs medicaux.
• Expertise demontree en controles de conception, gestion des risques (ISO 14971), reglementation des systemes qualite (21 CFR 820) et systemes de gestion de la qualite (ISO 13485).
• Capacite demontree a diriger de facon autonome des projets complexes de developpement de produits, y compris les activites d'assurance qualite des logiciels et des systemes, de leur conception a leur realisation.
• Experience dans l'elaboration et le maintien de la documentation de gestion des risques, notamment les AMDE (FMEA) et les analyses des dangers, avec une perspective integrant le materiel, les logiciels et les systemes.
• Excellentes aptitudes a la resolution de problemes, avec experience dans la conduite d'analyses des causes fondamentales et d'enquetes CAPA.
• Excellentes competences en communication, avec la capacite d'influencer des intervenants a tous les niveaux et de diriger des initiatives multidisciplinaires.
• Capacite a evoluer dans un environnement dynamique et a gerer l'ambiguite avec discernement.

Qualifications privilegiees

• Experience en mentorat ou en leadership d'ingenieurs juniors dans le cadre d'activites d'assurance de la conception ou d'ingenierie logicielle/systemes.
• Experience avec les equipements d'immobilisation (Capital Equipment).
• Connaissance des normes de qualite logicielle (IEC 62304) et des principes de developpement logiciel et systeme.
• Experience prealable sur des systemes de cartographie cardiaque ou des plateformes de dispositifs medicaux complexes similaires.
• Solides competences en gestion de projet et connaissance des methodologies de developpement Agile.

Requisition ID: 629845

Minimum Salary: $69,400 

Maximum Salary: $118,400 

The anticipated compensation and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Compensation for hourly, non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

Our organization is across Canada and has commercial representation in 140 countries.

This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.

As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Design Quality III / Qualite de conception III position require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Design Quality III / Qualite de conception III position.

However, in Quebec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee's duties.

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!