Senior Quality Manager – NPI & Launch Excellence

Pizzería Carlos

Valencia

On-site

EUR 90,000 - 130,000

Full time

3 days ago

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Job summary

Celestica is seeking a Senior Quality Manager focused on New Production Introduction (NPI) across HealthTech sites in Europe. You will lead quality planning, DFx strategies, and launch readiness to ensure seamless transitions from design to mass production while meeting ISO 13485 and other regulatory requirements.

The role requires deep expertise in QMS, analytics, and process deployment to build robust, compliant quality systems and capabilities across sites.

Qualifications

ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards expert.
NPI quality planning with processes and tools to meet objectives.
Advanced quality tools: FMEA, 8D, CCB, MQS.
Validation strategies (IQ/OQ/PQ) and DFx know-how.
Performance analytics and Monthly Operations Reviews for improvement.

Responsibilities

Lead Quality Planning & Strategy to deploy QMS processes and tools.
Drive DFx reviews and validation readiness for design-to-mass production.
Oversee Launch Readiness, MORs and Customer Satisfaction surveys.
Ensure conformance to international regulations and customer certifications (ISO 13485, ANSI/ESD).
Analyze customer scorecards and regulatory audits to close gaps with action plans.
Own global QMS processes to ensure regulatory compliance and risk mitigation.
Document and deploy global quality processes aligned with corporate initiatives.
Educate sites on global procedures to build high-functioning quality teams.