NPI Quality & DFx Lead (ISO 13485)

Assist Digital

Valencia

On-site

EUR 90,000 - 120,000

Full time

4 days ago

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Job summary

Celestica is seeking a Senior Quality Manager with an NPI focus to lead QMS deployment and ensure smooth transitions from design to mass production. You will drive regulatory compliance, DFx reviews, and launch readiness across HealthTech sites in Europe.

With 15+ years in quality leadership, you will oversee data analytics, customer scorecards, and audits while building global process ownership and high-performing teams for long-term quality excellence.

Qualifications

Expert knowledge of ISO 13485, 21 CFR 820 and ANSI/ISO/ESD standards.
Deep proficiency in defining quality processes and tools to meet objectives.
Mastery of FMEA, 8D, CCB protocols, and MQS.
Knowledge of validation strategies IQ/OQ/PQ and DFx to ensure transitions.
Ability to analyze quality data and drive improvement.

Responsibilities

Lead design and deployment of QMS processes and tools to meet NPI objectives.
Drive DFx reviews and validation strategies for smooth transitions to mass production.
Manage launch readiness, monthly reviews, and customer surveys for excellence.
Ensure site conformance to ISO 13485, ANSI/ESD and other regulations.
Analyze scorecards and audits to identify gaps and plan actions.
Develop and support global QMS processes to mitigate risks.
Document and deploy global quality processes aligning with corporate initiatives.
Educate sites on procedures to build independent quality teams.