Spécialiste de La Qualité Ii/quality Specialist Ii

**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.

**About the role**

**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.
- 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 skills
- Excellent attention to detail
- Requires mínimal supervision
- Willingness to learn and grow within the Quality Organization

**Preferred Qualifications**:

- Engineering or Health Science related degree
- Experience with ISO 13485? YES
- Internal Auditor Certification
- Quality Management Certification

**À propos du poste**

Le spécialiste de la qualité II assure un soutien en matière d’ingénierie de la qualité aux activités de R. et D. et contribue aux efforts d’amélioration du site. Il doit notamment produire, analyser et compiler les paramètres et les présentations nécessaires pour répondre aux exigences des systèmes d’assurance de la qualité et de l’ingénierie. Il doit en outre participer à l’exécution de projets visant à améliorer la conformité, l’efficience et l’efficacité des systèmes d’assurance de la qualité qui lui sont confiés.

**Responsabilités**
- Coordonner et maintenir les données du système d’assurance de la qualité pour aider la haute direction à procéder à une évaluation critique du bon fonctionnement du système d’assurance de la qualité.
- Créer des présentations de synthèse de l’analyse qui seront examinées par divers acteurs clés.
- Travailler avec l’AQ et la R. et D. pour repérer les domaines du système d’assurance de la qualité et de contrôle la conception qui ont besoin d’être améliorés et exécuter les mesures de gestion des événements de non-conformité ainsi que les mesures correctives et préventives, le cas échéant.
- Contribuer à la gestion du portefeuille des systèmes d’assurance de la qualité et de contrôle de la conception en surveillant ceux-ci, en assurant leur suivi et en fournissant à la direction des données relatives au système d’assur