Req ID:

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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 integral quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives.
Training & Capability Building

: Educate sites on global 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.

📌 Mozo De Almacén: Carga/Descarga Y Gestión (Valencia)
🏢 Valencia 24 horas
📍 Valencia