Integral Quality Senior Manager - NPI 1
Senior Quality Manager - New Production Introduction (NPI) Focus
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.
Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites.
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: Process Deployment: Document and deploy global 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.
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, and Manufacturing Quality Standards (MQS).
Performance Analytics: Ability to assess quality performance data to establish metrics, targets, and improvement strategies (e.g., Monthly Operations Reviews, Quality Excursion Reporting).
15+ years of progressive experience in Quality Management, with a proven track record in NPI , manufacturing scale-up, and global QMS deployment.
Bachelor's Degree or higher in Engineering, Quality Management or a related technical field.
All qualified applicants will receive consideration for employment and will not be discriminated agai

📌 Global Quality Senior Manager (Monterrey)
🏢 Celestica
📍 Monterrey