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 general medical technology leader and a chance to set the foundation for a pivotal production hub. * Head of Quality for the new site, defining structure, capabilities and strategy * Design and implement the Quality Management System aligned with global standards * Ensure Quality integration across construction, commissioning, validation and start-up activities * Lead site-wide quality, compliance, risk management and continuous improvement programs * 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 * 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 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 bu

📌 Vp Quality (Comunidad Valenciana)
🏢 Page Executive
📍 Comunidad Valenciana