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Manager, General Quality
Date:

Sep 25, 2026

Summary
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 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.

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 Manufactu

📌 Manager, Global Quality (Madrid)
🏢 Celestica
📍 Madrid