Integral Quality Manager - New Product 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.
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 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.
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, and Manufacturing Quality Standards (MQS).
Validation & DFx:
Technical understanding of validation strategies (IQ/OQ/PQ) and Design for

📌 Global Quality Manager (España)
🏢 Celestica
📍 España