Líder Global de Calidad para NPI e Implementación

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

Job summary

Celestica is seeking a Senior Quality Manager to lead NPI-focused quality management, DFx validation, and regulatory compliance across HealthTech sites in Europe. You will drive the deployment of global QMS processes, oversee launch readiness, and manage continuous improvement through data-driven insights.

The role requires extensive experience in quality systems, NPI programs, and cross-functional leadership, with a focus on early readiness, risk mitigation, and customer satisfaction across

Qualifications

• Bachelor's or higher in Engineering, Quality Management or related field.
• Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor, etc).
• Deep knowledge of ISO 13485 and quality systems in medical device environments.

Responsibilities

• Quality Planning & Strategy: Lead the design and deployment of QMS processes and tools to meet NPI objectives and customer requirements.
• DFx & Technical Readiness: Drive DFx reviews and oversight on validation strategies (IQ/OQ/PQ) for seamless design-to-mass production transitions.
• Launch Readiness: Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys for HealthTech sites.
• Regulatory Oversight: Ensure site-wide conformance to international regulations and customer certifications (e.g., ISO 13485, ANSI/ESD).
• Performance Monitoring: Analyze data from customer scorecards, regulatory audits, and operations to identify gaps and communicate actions.
• Global QMS process ownership: Develop and support key QMS processes to ensure regulatory compliance and risk mitigation.
• Process Deployment: Document and deploy global quality processes (Audit Compliance, Customer Feedback) aligned with corporate initiatives.
• Training & Capability Building: Educate sites on global procedures to build high-functioning quality teams.

Skills

QMS design & deployment

ISO 13485 knowledge

DFx & validation (IQ/OQ/PQ)

NPI quality planning

Performance analytics

Regulatory compliance

Data analysis

Education

Bachelor's or higher in Engineering/Quality

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

Job description

Celestica is seeking a Senior Quality Manager to lead NPI-focused quality management, DFx validation, and regulatory compliance across HealthTech sites in Europe. You will drive the deployment of global QMS processes, oversee launch readiness, and manage continuous improvement through data-driven insights.

The role requires extensive experience in quality systems, NPI programs, and cross-functional leadership, with a focus on early readiness, risk mitigation, and customer satisfaction across