Req ID:Remote Position: NoRegion: EuropeCountry: SpainState/Province: La Pobla De VallbonaCity: ValenciaSummary Senior Quality Manager - New Production Introduction (NPI) FocusDetailed 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.Advanced Quality Tools : Mastery of core quality methodologies, including FMEA (Failure Mode and Effects Analysis), 8D Methodology, Change Control Board (CCB) protocols,