Vp Quality - Page Executive

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.

• 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 xcskxlj 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

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