Job Description

Additional Locations: Canada-QC-MontrealDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 roleThe Quality Specialist II will provide Quality Engineering support to R&D activities and assisting in site improvement efforts. This includes generation, analysis and compilation of required metrics and presentations to support Quality Systems and Engineering requirements. In addition, the successful candidate will assist in the execution of projects designed to improve the compliance, efficiency, and effectiveness of assigned quality systems.Your responsibilities will include:Coordinate and maintain Quality system data to assist senior leaders in making critical assessment of the health of the quality systemCreate summary presentations of the analysis for review by a variety of key stakeholders.Work with QA and R&D to identify areas within the quality system and design assurance in need of improvement and execute NCEPs and Corrective and Preventive Actions as appropriate.Assist in the Quality Systems and Design Assurance portfolio management by monitoring, tracking, and providing data to management around the quality system for review in templates and presentations.Provide data to project/department managers on status of project metrics for their assigned project including tracking milestones, budget attainment, and other relevant metrics.Prepares new and revised documents for routing per the local document approval process. Tracks progress in obtaining approvals to for document change notices to aid in timely approvals.Incorporates documentation edits and updates all logs associated with documentation status. Releases approved documents and notifies affected personnel of changes impacting functional areas.Suggests changes to processes documentation and training programs in the spirit of continuous improvement.Supports teams in implementation of quality systems upgrades.Monitors and documents compliance with the local training program to ensure training compliance.Manages the biennial review of documentation system to ensure compliance to standards.Conducts internal audits as needed and supports regulatory, notified body and corporate external audits.Interacts between functional groups regard Document Change Notices.Facilitates Document Review meeting and makes recommendations as needed to functional areas.Support quality related needs of various departments and processes, including Design & Development and Non-Device Software & Equipment Controls. This includes validation documentation, and quality planning support.Root Cause Analysis of system/product non-conformances as discovered by Manufacturing, Customers, and Internal and External audits.Support the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.May Actively participate in New Product Development, Design Review, and Design Control Activities.Required qualifications:Undergraduate or master's degree in a science, business or related field.2-4 years of relevant experience in a quality-related role.Experience in a regulated industry (i.e., pharmaceutical, automobile, aerospace, etc.)Strong documentation and writing skillsExcellent attention to detailRequires minimal supervisionWillingness to learn and grow within the Quality OrganizationPreferred Qualifications:Engineering or Health Science related degreeExperience with ISO 13485? YESInternal Auditor CertificationQuality Management Certificationxc3x80 propos du posteLe spxc3xa9cialiste de la qualitxc3xa9 II assure un soutien en matixc3xa8re d'ingxc3xa9nierie de la qualitxc3xa9 aux activitxc3xa9s de R. et D. et contribue aux efforts d'amxc3xa9lioration du site. Il doit notamment produire, analyser et compiler les paramxc3xa8tres et les prxc3xa9sentations nxc3xa9cessaires pour rxc3xa9pondre aux exigences des systxc3xa8mes d'assurance de la qualitxc3xa9 et de l'ingxc3xa9nierie. Il doit en outre participer xc3xa0 l'exxc3xa9cution de projets visant xc3xa0 amxc3xa9liorer la conformitxc3xa9, l'efficience et l'efficacitxc3xa9 des systxc3xa8mes d'assurance de la qualitxc3xa9 qui lui sont confixc3xa9s.Responsabilitxc3xa9sCoordonner et maintenir les donnxc3xa9es du systxc3xa8me d'assurance de la qualitxc3xa9 pour aider la haute direction xc3xa0 procxc3xa9der xc3xa0 une xc3xa9valuation critique du bon fonctionnement du systxc3xa8me d'assurance de la qualitxc3xa9.Crxc3xa9er des prxc3xa9sentations de synthxc3xa8se de l'analyse qui seront examinxc3xa9es par divers acteurs clxc3xa9s.Travailler avec l'AQ et la R. et D. pour repxc3xa9rer les domaines du systxc3xa8me d'assurance de la qualitxc3xa9 et de contrxc3xb4le la conception qui ont besoin d'xc3xaatre amxc3xa9liorxc3xa9s et exxc3xa9cuter les mesures de gestion des xc3xa9vxc3xa9nements de non-conformitxc3xa9 ainsi que les mesures correctives et prxc3xa9ventives, le cas xc3xa9chxc3xa9ant.Contribuer xc3xa0 la gestion du portefeuille des systxc3xa8mes d'assurance de la qualitxc3xa9 et de contrxc3xb4le de la conception en surveillant ceux-ci, en assurant leur suivi et en fournissant xc3xa0 la direction des donnxc3xa9es relatives au systxc3xa8me d'assurance de la qualitxc3xa9 xc3xa0 des fins d'examen au moyen de modxc3xa8les et de prxc3xa9sentations.Fournir des donnxc3xa9es aux gestionnaires de projets et de services sur l'xc3xa9tat des paramxc3xa8tres du projet qui leur est confixc3xa9, y compris le suivi des xc3xa9tapes, la tenue du budget et d'autres paramxc3xa8tres pertinents.Prxc3xa9parer des documents nouveaux et rxc3xa9visxc3xa9s afin que ceux-ci soient acheminxc3xa9s conformxc3xa9ment au processus local d'approbation des documents. Suivre l'xc3xa9volution de l'obtention des approbations pour les avis de modification des documents afin de faciliter les approbations en temps voulu.Incorporer les modifications apportxc3xa9es xc3xa0 la documentation et mettre xc3xa0 jour tous les registres associxc3xa9s xc3xa0 l'xc3xa9tat de la documentation. Diffuser les documents approuvxc3xa9s et informer le personnel concernxc3xa9 des changements ayant une incidence sur les domaines fonctionnels.Suggxc3xa9rer des modifications aux processus, xc3xa0 la documentation et aux programmes de formation dans un esprit d'amxc3xa9lioration continue.Soutenir les xc3xa9quipes dans la mise en xc5x93uvre des mises xc3xa0 niveau des systxc3xa8mes d'assurance de la qualitxc3xa9.Contrxc3xb4ler et documenter le respect du programme de formation local afin d'assurer la conformitxc3xa9 de la formation.Gxc3xa9rer l'examen semestriel du systxc3xa8me de documentation afin de s'assurer qu'il est conforme aux normes.Effectuer des vxc3xa9rifications internes selon les besoins et soutenir les vxc3xa9rifications rxc3xa9glementaires, les organismes dxc3xa9signxc3xa9s et les vxc3xa9rifications externes de l'entreprise.Interagir avec les groupes fonctionnels en ce qui concerne les avis de modification des documents.Animer des rxc3xa9unions d'examen des documents et formuler des recommandations, le cas xc3xa9chxc3xa9ant, xc3xa0 l'intention des secteurs fonctionnels.Rxc3xa9pondre aux besoins en matixc3xa8re de qualitxc3xa9 de divers services et processus, y compris les phases de conception et de dxc3xa9veloppement et les contrxc3xb4les de logiciels et d'xc3xa9quipements autres que les dispositifs. La documentation de validation et le soutien xc3xa0 la planification de la qualitxc3xa9 en font partie.Analyser les causes profondes des cas de non-conformitxc3xa9 des systxc3xa8mes/produits dxc3xa9couverts par le service de la fabrication, les clients et les vxc3xa9rifications internes et externes.Soutenir la mise en xc5x93uvre des mxc3xa9canismes d'assurance, des contrxc3xb4les de processus et des systxc3xa8mes de prise de mesures correctives et prxc3xa9ventives qui rxc3xa9pondent aux exigences internes et externes, voire les dxc3xa9passent.Participer activement au dxc3xa9veloppement de nouveaux produits, xc3xa0 l'examen de la conception et aux activitxc3xa9s de contrxc3xb4le de la conception.Qualifications requisesDiplxc3xb4me de premier cycle ou maxc3xaetrise en sciences, en commerce ou dans un domaine connexe.De 2 xc3xa0 4 annxc3xa9es d'expxc3xa9rience pertinente dans un rxc3xb4le lixc3xa9 xc3xa0 la qualitxc3xa9.Expxc3xa9rience dans un secteur rxc3xa9glementxc3xa9 (pharmaceutique, automobile, axc3xa9rospatiale, etc.).Solides compxc3xa9tences en matixc3xa8re de documentation et de rxc3xa9daction.Grand souci du dxc3xa9tail.Requiert un minimum de supervision.Volontxc3xa9 d'apprendre et d'xc3xa9voluer au sein du service d'assurance de la qualitxc3xa9.Qualifications souhaitxc3xa9esDiplxc3xb4me en gxc3xa9nie ou en sciences de la santxc3xa9Expxc3xa9rience relative xc3xa0 la norme ISO 13485? OUICertification en vxc3xa9rification interneCertification en gestion de la qualitxc3xa9Requisition ID: 604312Minimum Salary: $57200Maximum Salary: $113700The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see --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).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!