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 The Quality Specialist II will provide Quality Engineering support to R and 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 system : Create summary presentations of the analysis for review by a variety of key stakeholders. : Work with QA and R and 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 and development and non:device software and 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 masters degree in a science, business or related field. : 2+ 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 minimal supervision : Willingness to learn and grow within the Quality Organ