Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité

Boston Scientific; Montreal; On-site; CAD 79,000 - 159,000; Full time

Job summary

A leading medical technology company is seeking a Senior Design Quality Assurance Engineer in Montreal. The role involves leading quality assurance for innovative cardiovascular products, ensuring compliance with regulatory standards, and collaborating on product development. Candidates should have a bachelor's degree in engineering and relevant experience in quality assurance, specifically within medical devices. This position offers a competitive salary range of $79,700 to $158,200.

Qualifications

• 7+ years of work experience in quality assurance in a highly regulated industry.
• Experience in medical devices is preferred.

Responsibilities

• Develop understanding of Design Controls and Risk Management for Medical Devices.
• Provide quality and compliance input to project teams.
• Support internal and external regulatory audits.

Skills

Attention to detail

Organizational skills

Communication skills (oral and written)

Problem-solving

Education

Bachelor's degree in mechanical, electrical, or biomedical engineering

Tools

Microsoft Office Suite

Job description

Additional 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 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 7ans 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:617682

Minimum Salary: $79700

Maximum Salary: $158200

The anticipated compensation listed above 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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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 Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualitéposition 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 Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualitéposition.

However, in Québec, 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.