Principal Quality Specialist

Additional Locations: Netherlands-Kerkrade; France-Voisins le Bretonneux; Germany-Düsseldorf; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; Italy-Milan; United Kingdom-Hemel Hempstead

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.

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 global 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.
• 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.