Senior 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 Health Tech 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 global quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives. Training & Capability Building:
Educate sites on integral 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), 8 D 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 products Typical Experience
15+ years
of progressive experience in Quality Management, with a proven track record in
NPI , manufacturing scale-up, and global QMS deployment. Typical Education
Bachelor’s Degree or higher in Engineering, Quality Management or a related technical field. Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor, etc).

📌 Sr Manager Global Quality (Ciudad Apodaca)
🏢 Celestica
📍 Ciudad Apodaca