Req ID:

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Remote Position: No
Region: Europe
Country: Spain
State/Province: La Pobla De Vallbona
City: Valencia
SummarySenior 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 general 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.
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