Spcialiste de la qualit IIQuality Specialist II 604312

Additional Locations:CanadaQCMontreal

Diversity Innovation Caring Global Collaboration Winning Spirit High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and highperforming employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role

The 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 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 system

• Create 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.

• Assists 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.

• Providedata to project/department managers on status of project metrics for their assigned project including tracking milestones budget attainment and other relevant metrics.

• Preparenew 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.

• Incorporatedocumentation edits and updates all logs associated with documentation status. Releases approved documents and notifies affected personnel of changes impacting functional areas.

• Suggestchanges to processes documentation and training programs in the spirit of continuous improvement.

• Supportteams in implementation of quality systems upgrades.

• Monitorand documents compliance with the local training program to ensure training compliance.

• Managethe biennial review of documentation system to ensure compliance to standards.

• Conductinternal audits as needed and supports regulatory notified body and corporate external audits.

• Interactbetween functional groups regard document change notices.

• Facilitatedocument review meeting and makes recommendations as needed to functional areas.

• Support quality related needs of various departments and processes including design & development and nondevice software & equipment controls. This includes validation documentation and quality planning support.

• Root cause analysis of system/product nonconformances 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 masters degree in a science business or related field.

• 2 years of relevant experience in a qualityrelated role.

• Experience in a regulated industry (i.e. pharmaceutical automobile aerospace etc.

• Strong documentation and writing skills

• Excellent attention to detail

• Requires minimal supervision

• Willingness to learn and grow within the Quality Organization

Preferred Qualifications:

• Engineering or Health Science related degree

• Experience with ISO 13485

• Internal Auditor Certification

• Quality Management Certification

propos du poste

Le spcialiste de la qualitII assure un soutien en matire dingnierie de la qualit aux activits de R. et D. et contribue aux efforts damlioration du site. Il doit notamment produire analyser et compiler les paramtres et les prsentations ncessaires pour rpondre aux exigences des systmes dassurance de la qualit et de lingnierie. Il doit en outre participer lexcution de projets visant amliorer la conformit lefficience et lefficacit des systmes dassurance de la qualit qui lui sont confis.

Responsabilits

• Coordonner et maintenir les donnes du systme dassurance de la qualit pour aider la haute direction procder une valuation critique du bon fonctionnement du systme dassurance de la qualit.

• Crer des prsentations de synthse de lanalyse qui seront examines par divers acteurs cls.

• Travailler avec lAQ et la R. et D. pour reprer les domaines du systme dassurance de la qualit et de contrle la conception qui ont besoin dtre amliors et excuter les mesures de gestion des vnements de nonconformit ainsi que les mesures correctives et prventives le cas chant.

• Contribuer la gestion du portefeuille des systmes dassurance de la qualit et de contrle de la conception en surveillant ceuxci en assurant leur suivi et en fournissant la direction des donnes relatives au systme dassurance de la qualit des fins dexamen au moyen de modles et de prsentations.

• Fournir des donnes aux gestionnaires de projets et de services sur ltat des paramtres du projet qui leur est confi y compris le suivi des tapes la tenue du budget et dautres paramtres pertinents.

• Prparer des documents nouveaux et rviss afin que ceuxci soient achemins conformment au processus local dapprobation des documents. Suivre lvolution de lobtention des approbations pour les avis de modification des documents afin de faciliter les approbations en temps voulu.

• Incorporer les modifications apportes la documentation et mettre jour tous les registres associs ltat de la documentation. Diffuser les documents approuvs et informer le personnel concern des changements ayant une incidence sur les domaines fonctionnels.

• Suggrer des modifications aux processus la documentation et aux programmes de formation dans un esprit damlioration continue.

• Soutenir les quipes dans la mise en uvre des mises niveau des systmes dassurance de la qualit.

• Contrler et documenter le respect du programme de formation local afin dassurer la conformit de la formation.

• Grer lexamen semestriel du systme de documentation afin de sassurer quil est conforme aux normes.

• Effectuer des vrifications internes selon les besoins et soutenir les vrifications rglementaires les organismes dsigns et les vrifications externes de lentreprise.

• Interagir avec les groupes fonctionnels en ce qui concerne les avis de modification des documents.

• Animer des runions dexamen des documents et formuler des recommandations le cas chant lintention des secteurs fonctionnels.

• Rpondre aux besoins en matire de qualit de divers services et processus y compris les phases de conception et de dveloppement et les contrles de logiciels et dquipements autres que les dispositifs. La documentation de validation et le soutien la planification de la qualit en font partie.

• Analyser les causes profondes des cas de nonconformit des systmes/produits dcouverts par le service de la fabrication les clients et les vrifications internes et externes.

• Soutenir la mise en uvre des mcanismes dassurance des contrles de processus et des systmes de prise de mesures correctives et prventives qui rpondent aux exigences internes et externes voire les dpassent.

• Participer activement au dveloppement de nouveaux produits lexamen de la conception et aux activits de contrle de la conception.

Qualifications requises

• Diplme de premier cycle ou matrise en sciences en commerce ou dans un domaine connexe.

• De 2 4annes dexprience pertinente dans un rle li la qualit.

• Exprience dans un secteur rglement (pharmaceutique automobile arospatiale etc..

• Solides comptences en matire de documentation et de rdaction.

• Grand souci du dtail.

• Requiert un minimum de supervision.

• Volont dapprendre et dvoluer au sein du service dassurance de la qualit.

Qualifications souhaites

• Diplme en gnie ou en sciences de la sant

• Exprience relative la norme ISO13485

• Certification en vrification interne

• Certification en gestion de la qualit

Requisition ID:604312

Minimum Salary: $57200

Maximum Salary: $113700

The 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 nonsales 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 nonsales roles may also include variable compensation i.e. annual bonus target and longterm incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual nondiscretionary 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) isnt just business its personal. And if youre a natural problemsolver 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!