Descripción de la oferta
Experteer Overview As a Principal Quality Specialist, you will lead quality initiatives for large-scale MEE/Capital Equipment programs, shaping governance and quality frameworks across global teams. You’ll drive regulatory alignment, risk management, and continuous improvement to enable operational excellence. The role offers autonomy and strategic influence across regions, with hybrid or onsite work in Kerkrade or other EMEA hubs. You’ll collaborate with cross-functional partners to advance quality objectives and adoption of new processes. This is a mission-driven opportunity to elevate quality systems in a global medical technology leader.Compensaciones / Beneficios
- Lead quality activities for complex MEE/Capital Equipment programs to meet objectives, milestones, and timelines
- Coordinate across regional and global teams to align Quality, Regulatory, Supply Chain, Service, and commercial functions
- Serve as SME in Quality Systems, ensuring compliance with ISO 13485, EU MDR 2017/745, and 21 CFR Part 820 across all program phases
- Lead or support CAPA, root cause analysis, and continuous improvement initiatives
- Collaborate with cross-functional colleagues on impacts of enhancements and process changes
- Promote awareness of QSR and ISO/MDR standards within the group and with EMEA Quality leaders
- Drive change management and cross-functional engagement to enable adoption of new processes and ways of working in a matrixed global organizationResponsabilidades
- Bachelor's or Master's degree in engineering, Quality, Life Sciences, or related field
- 5+ years Quality Systems experience in Medical Devices / MEE / Capital Equipment
- Experience leading large-scale, cross-functional/global programs
- Experience in change management and transformation initiatives
- 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 in ambiguous or evolving environmentsRequisitos principales
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