About the role:

The 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.

Por favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de interés.

We 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.

This position will be either hybrid or onsite located at Kerkrade in the Netherlands or at one of the EMEA Hub locations.

Key Responsibilities:

- Lead 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.
- Drive execution across regional and global teams, aligning Quality, Regulatory, Supply Chain, Service, and commercial functions while proactively managing risks, issues, and dependencies.
- Serve 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.
- Lead or support CAPA, root cause analysis,



and continuous improvement initiatives to resolve systemic issues and enhance overall performance.
- Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
- Is 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.
- Drive 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 integral organization.

Requirements:
- Bachelor’s or Master’s degree in engineering, Quality, Life Sciences, or related field
- 5+ years Quality Systems experience in within Medical Devices / Medical Electrical Equipment (MEE) / Capital Equipment.
- Previous experience in Capital Equipment space is preferable. xqbhyrx
- Proven experience leading large-scale, cross-functional and/or global programs
- Experience in change management and transformation initiatives
- Team player with strong work ethics and positive mentality
- Strong project and program management capability
- Strong interpersonal communication, collaboration and influencing skills
- Deep regulatory and quality systems knowledge
- Excellent stakeholder management and influencing skills
- Structured, analytical mindset
- Ability to operate effectively in ambiguous or evolving environments, where requirements are not fully defined.

Requisition ID:630856

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📌 Principal Quality Specialist (Madrid)
🏢 Boston Scientific Gruppe
📍 Madrid