Principal Quality Specialist
HybridKerkrade, Limburg, The Netherlands
Kerkrade, Limburg, The NetherlandsHybridFull TimeSenior LevelMasters DegreeLarge
Full TimeSenior LevelMasters DegreeLarge
Job Summary
Senior Quality leadership role leading cross-functional MEE/Capital Equipment programs, developing and governing quality frameworks, ensuring regulatory compliance (ISO 13485, EU MDR 2017/745, 21 CFR Part 820). Drives CAPA and root-cause analysis, leads or supports continuous improvement, and coordinates with Regulatory, Supply Chain, Service, and Commercial teams in a global matrix. Influences decision-making, champions change management, and promotes best practices in QSR and ISO/MDR standards. Hybrid or onsite located at Kerkrade, Netherlands, or at one of the EMEA Hub locations.
Required Qualifications
- 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
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