Senior 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 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.Quality 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 Quality Standards (MQS).
Validation & DFx: Technical understanding of validation strategies (IQ/OQ/PQ) and Design for Excellence (DFx) to ensure seamless transitions from design to mass production.Performance Analytics: Ability to assess quality performance data to establish metrics, targets, and improvement strategies (e.g., Monthly Operations Reviews, Quality Excursion Reporting).
Experience on manufacture of electronic productsTypical Experience15+ years of progressive experience in Quality Management, with a proven track record in NPI, manufacturing scale-up, and global QMS deployment.Typical EducationBachelor's Degree or higher in Engineering, Quality Management or a related technical field.Industry certifications preferred (ASQ, Six Sigma, ISO***** Lead Auditor, etc).
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📌 Sr Manager Global Quality - Healthtech, Npi And Electronics (Ciudad Apodaca)
🏢 Celestica
📍 Ciudad Apodaca