Senior Quality & NPI Leader — DFx & ISO13485 Expert

Boluda Group; Valencia; On-site; EUR 95,000 - 135,000; Full time

Job summary

Celestica in Europe is seeking a Senior Quality Manager focused on New Production Introduction (NPI) to lead QMS design, DFx and regulatory readiness across HealthTech sites in Spain.

You will drive launch readiness, monitor performance via scorecards and audits, and build capable, independent quality teams, ensuring ISO 13485 and related standards are met while enabling smooth transitions from design to mass production.

Qualifications

• 15+ years in Quality Management with NPI and manufacturing scale-up.
• Experience deploying global QMS across multiple sites.
• Strong knowledge of ISO 13485, 21 CFR 820 and ANSI/ISO/ESD.

Responsibilities

• Lead the design and deployment of QMS processes and tools.
• Drive DFx reviews and validation strategies (IQ/OQ/PQ).
• Manage launch readiness assessments and customer satisfaction surveys.
• Ensure regulatory conformance and customer certifications.
• Analyze quality performance data and communicate action plans.

Skills

Quality Frameworks

NPI Quality Planning

Advanced Quality Tools

Validation & DFx

Performance Analytics

Education

Bachelor's Degree or higher in Engineering/Quality

Industry certifications (ASQ, Six Sigma, ISO13485 Lead Auditor)

Job description

Celestica in Europe is seeking a Senior Quality Manager focused on New Production Introduction (NPI) to lead QMS design, DFx and regulatory readiness across HealthTech sites in Spain.

You will drive launch readiness, monitor performance via scorecards and audits, and build capable, independent quality teams, ensuring ISO 13485 and related standards are met while enabling smooth transitions from design to mass production.