Overview
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As VP of Quality, you will lead the Quality function for a new Valencia manufacturing site, shaping the site’s Quality strategy and building the Quality Management System from scratch. You will integrate quality and regulatory requirements across construction, commissioning, validation, and ramp-up, while supporting technology transfer and process scale-up. You will lead cross-functional teams, drive compliance, and establish a culture focused on patient safety and continuous improvement. This role offers strategic influence at site level within a global medical technology leader and a chance to set the foundation for a pivotal production hub.
Responsabilidades
Head of Quality for the new site, defining structure, capabilities and strategy
Design and implement the Quality Management System aligned with integral standards
Ensure Quality integration across construction, commissioning, validation and start-up activities
Lead site-wide quality, compliance, risk management and continuous improvement programs
Drive audit readiness during site development and ramp-up
Establish and monitor quality KPIs and escalation mechanisms
Recruit,



develop and lead multidisciplinary Quality teams
Lead regulatory interactions with European and global health authorities
Ensure compliance with applicable international regulatory frameworks
Promote a strong quality and compliance culture across the organization
Requisitos principales
Extensive manufacturing quality leadership experience in medical devices
Experience with implantable devices preferred (Class III)
Deep knowledge of global regulatory frameworks (FDA QSR/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971)
Direct experience supporting facility start-up, site expansion or technology xqbhyrx transfer
Proven track record building, implementing and sustaining robust QMS in operations
Experience leading regulatory interactions including FDA inspections and Notified Body audits
Solid understanding of GMP and lifecycle regulatory expectations
strong leadership in matrixed, multicultural environments
ability to build and develop high-performing teams
pragmatic and hands-on mindset with strategic thinking
Quality Management System design and implementation
Regulatory compliance with FDA, EU MDR, ISO standards
Process validation and technology transfer

📌 VP Quality (Valencia)
🏢 Page Executive
📍 Valencia