Global Head, NPI Quality & DFx Excellence

Anthesis Group

Valencia

In loco

EUR 90.000 - 120.000

Tempo pieno

2 giorni fa

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Descrizione del lavoro

Celestica seeks a Senior Quality Manager to lead the New Production Introduction (NPI) quality program from Valencia, Spain. You will own DFx strategies, validate IQ/OQ/PQ plans, and drive readiness for product launches at HealthTech sites.

You will oversee QMS deployment, regulatory alignment, and data-driven improvements across global operations, ensuring customer satisfaction and defect-free transitions from design to mass production.

Competenze

Bachelor's Degree or higher in Engineering, Quality Management or related field.
15+ years of progressive experience in Quality Management.
Experience in NPI, manufacturing scale-up and global QMS deployment.
Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor).
Knowledge of ISO 13485, FDA 21 CFR 820 and ANSI/ISO/ESD standards.

Mansioni

Lead the design and deployment of QMS processes and tools to meet NPI objectives and customer requirements.
Drive DFx reviews and validation strategies (IQ, OQ, PQ) for design-to-mass production transitions.
Manage launch readiness assessments, Monthly Operations Reviews, and customer satisfaction surveys.
Ensure site-wide conformance to international regulations and customer certifications (ISO 13485, ANSI/ESD).
Analyze data from customer scorecards, regulatory audits, and performance to identify gaps and action plans.
Develop and support global QMS processes to ensure regulatory compliance and mitigate risks.
Document and deploy global quality processes (Audit Compliance, Customer Feedback) aligned with corporate initiatives.
Educate sites on global procedures to build independent, high-functioning quality teams.