Req ID: Remote Position: No Region: Europe Country: Spain State/Province: La Pobla De Vallbona City: Valencia Summary Senior Quality Manager - New Production Introduction (NPI) Focus Detailed Description * Quality 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: Drive Design 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 general procedures to build independent, high-functioning quality teams capable of maintaining long-term quality initiatives. Knowledge/Skills/Competencies * 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 Co

📌 Almacenista: Gestión De Inventarios Y Optimización (Andalucía)
🏢 Grupo Balak
📍 Andalucía