Global Quality Manager - New Product Introduction (NPI) FocusQuality Planning & Strategy:Lead the design and deployment of Quality Management Systems (QMS) processes and tools to ensure NPI objectives and customer requirements are met.DFx & Technical Readiness:DriveDesign for Excellence (DFx)reviews and oversight on validation strategies (IQ,OQ,PQ) to ensure seamless product transitions from design to mass production.Launch Readiness:Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites.Regulatory Oversight:Ensure site-wide conformance to international regulations and customer certifications (e.G.,ISO 13485, ANSI/ESD ).Performance Monitoring:Analyze data from customer scorecards, regulatory audits,



and operational performance to identify gaps and communicate action plans to stakeholders.Global QMS process ownership:Develop and support key QMS processes to ensure regulatory compliance and mitigate operational risks.Process Deployment:Document and deploy global quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives.Training & Capability Building:Educate sites on integral procedures to build independent, high-functioning quality teams capable of maintaining long-term quality initiatives.Quality Frameworks:Expert-level knowledge of ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards.NPI Quality Planning:Deep proficiency in defining critical quality business processes, tools, and system applications required to meet site-level and customer-specific quality objectives.Advanced Quality Tools:Mastery of core quality methodologies, including FMEA (Failure Mode and Effects Analysis), 8D Methodology, Change Control Board (CCB) protocols, and Manufacturing Quality Standards (MQS).Validation & DFx:Technical understanding of validation strategies (IQ/OQ/PQ) and Design for Excellence (DFx) to ensure seamless transitions from des

📌 Global Quality Manager (Madrid)
🏢 Celestica
📍 Madrid