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 Contro

📌 Coordinador De Obras Y Edificación | Gestión De Proyectos (Madrid)
🏢 GRUPO FUCSA
📍 Madrid