ppbAdditional Locations: /b Netherlands-Kerkrade; France-Voisins le Bretonneux; Germany-Düsseldorf; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; Italy-Milan; United Kingdom-Hemel Hempstead /p pDiversity - Innovation - Caring - Integral Collaboration - Winning Spirit - High Performance /p pAt 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. /p h3About the role: /h3 pThe Principal Quality Specialist serves as a senior Quality leader supporting large-scale, complex initiatives within the Medical Electrical Equipment (MEE) / Capital Equipment domain. You will drive the development, implementation, and governance of quality frameworks across global, cross-functional programs. /p pWe are looking for a candidate with strong leadership in quality systems, project execution, and organizational change, ensuring alignment with regulatory requirements, corporate quality goals, and operational excellence. The role operates with a high degree of autonomy and influences strategic decision-making across multiple functions and regions. /p pThis position will be either hybrid or onsite located at Kerkrade in the Netherlands or at one of the EMEA Hub locations. /p h3Key Responsibilities: /h3 ul liLead Quality activities for complex, cross-functional Medical Electrical Equipment (MEE)/Capital Equipment programs, ensuring delivery against objectives, milestones, and timelines through robust project planning and risk mitigation. /li liDrive execution across regional and global teams, aligning Quality, Regulatory, Supply Chain, Service, and commercial functions while proactively managing risks, issues, and dependencies.



/li liServe as a subject matter expert in Quality Systems, ensuring compliance with applicable regulatory standards such as ISO 13485, EU MDR 2017/745, and 21 CFR Part 820, and embedding scalable Quality frameworks across all program phases from concept through sustainment. /li liLead or support CAPA, root cause analysis, and continuous improvement initiatives to resolve systemic issues and enhance overall performance. /li liCollaborate with cross-functional colleagues regarding the impacts of enhancements and process changes. /li liIs viewed as a leader in the areas of QSR and ISO/MDR standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions while collaborating with EMEA Quality leaders as appropriate on critical quality decisions. /li liDrive change management and cross-functional engagement by influencing decision-making, building stakeholder alignment, and enabling adoption of new processes, systems, and ways of working in a matrixed global organization. /li /ul h3Requirements: /h3 ul li​Bachelor’s or Master’s degree in engineering, Quality, Life Sciences, or related field /li li5+ years Quality Systems experience in within Medical Devices / Medical Electrical Equipment (MEE) / Capital Equipment. /li liPrevious experience in Capital Equipment space is preferable. /li liProven experience leading large-scale, cross-functional and/or global programs /li liExperience in change management and transformation initiatives /li liTeam player with strong work ethics and positive mentality /li liStrong project and program management capability /li liStrong interpersonal communication, collaboration and influencing skills /li liDeep regulatory and quality systems knowledge /li liExcellent stakeholder management and influencing skills /li liStructured, analytical mindset /li liAbility to operate effectively in ambiguous or evolving environments, where requirements are not fully defined. /li /ul pRequisition ID: /p /p #J-18808-Ljbffr

📌 Principal Quality Specialist (Madrid)
🏢 B Capital
📍 Madrid