Req ID:Remote Position: NoRegion: EuropeCountry: SpainState/Province: La Pobla De VallbonaCity: ValenciaSummarySenior Quality Manager - New Production Introduction (NPI) FocusDetailed DescriptionQuality 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 *, 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/CompetenciesQuality Frameworks: Expert-level knowledge of ISO *, 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 Qu

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