Global NPI Quality Leader — DFx & Regulatory Excellence

Grupo Térvalis; Valencia; On-site; EUR 90,000 - 120,000; Full time

Job summary

Celestica in Valencia, Spain is seeking a Senior Quality Manager focused on New Production Introduction (NPI) to lead the design and deployment of QMS processes across healthtech sites.

You will drive DFx reviews, validate IQ/OQ/PQ plans, manage launch readiness, and ensure ISO 13485 and related standards are met while monitoring performance through scorecards and audits. The role requires 15+ years in quality management and a proven ability to build capable cross-site teams.

Qualifications

• Bachelor's Degree or higher in Engineering or Quality Management with industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor).
• Extensive experience implementing QMS for NPI and manufacturing scale-up across global sites.
• Strong analytical and problem-solving skills with data-driven decision making.

Responsibilities

• Lead the design and deployment of QMS processes to meet NPI objectives and customer requirements.
• Drive DFx reviews and oversight on validation strategies (IQ, OQ, PQ) for smooth design-to-mass production transitions.
• Manage launch readiness assessments, Monthly Operations Reviews, and customer satisfaction surveys.
• Ensure site-wide conformance to ISO 13485 and related regulations and certifications.
• Analyze quality data, communicate gaps, and define action plans with stakeholders.
• Develop and own global QMS processes to mitigate operational risks.
• Document and deploy global quality procedures across sites and train teams accordingly.

Skills

Quality Frameworks

NPI Quality Planning

Advanced Quality Tools

Validation & DFx

Performance Analytics

Education

Bachelor's Degree or higher in Engineering/Quality Management

Job description

Celestica in Valencia, Spain is seeking a Senior Quality Manager focused on New Production Introduction (NPI) to lead the design and deployment of QMS processes across healthtech sites.

You will drive DFx reviews, validate IQ/OQ/PQ plans, manage launch readiness, and ensure ISO 13485 and related standards are met while monitoring performance through scorecards and audits. The role requires 15+ years in quality management and a proven ability to build capable cross-site teams.