Descripción de la oferta
ph3Principal Quality Specialist /h3pSenior quality leader supporting large‑scale, complex initiatives within the Medical Electrical Equipment (MEE) / Capital Equipment domain. This role drives the development, implementation, and governance of quality frameworks across global, cross‑functional programs, ensuring alignment with regulatory requirements, corporate quality goals, and operational excellence. /ppLocation: Hybrid or onsite at Kerkrade, Netherlands or one of the EMEA Hub locations. /ph3Key Responsibilities /h3ulliLead quality activities for complex, cross‑functional MEE/Capital Equipment programs, ensuring delivery against objectives, milestones, and timelines through robust project planning and risk mitigation. /liliDrive execution across regional and integral teams, aligning Quality, Regulatory, Supply Chain, Service, and commercial functions while proactively managing risks, issues, and dependencies. /liliServe as a subject‑matter expert in Quality Systems, ensuring compliance with ISO 13485, EU MDR 2017/745, and 21 CFR Part 820. /liliEmbed scalable quality frameworks across all program phases from concept through sustainment. /liliLead or support CAPA, root cause analysis, and continuous improvement initiatives to resolve systemic issues and enhance overall performance. /liliChampion 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 /ulh3Qualifications /h3ulliBachelor’s or Master’s degree in engineering, Quality, Life Sciences, or a related field. /lili5+ years of quality systems experience within Medical Devices / Medical Electrical Equipment (MEE) / Capital Equipment. /liliProven experience leading large‑scale, cross‑functional and/or global programs. /liliStrong project and program management capability. /liliDeep regulatory and quality systems knowledge. /li /ul /p #J-18808-Ljbffr
