Senior Quality Manager – NPI & DFx Leader

Valencia 24 Horas

Valencia

On-site

EUR 90,000 - 120,000

Full time

14 days+

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Job summary

Celestica is seeking a Senior Quality Manager to lead New Production Introduction (NPI) quality activities across HealthTech sites in Europe. You will own quality planning, DFx governance, and regulatory compliance to ensure smooth transitions from design to manufacturing.

The role focuses on driving launch readiness, performance analytics, and global QMS deployment, with a strong emphasis on DFx and validated processes to meet customer requirements.

Qualifications

  • 15+ years of progressive experience in Quality Management, with a proven track record in NPI, manufacturing scale-up and global QMS deployment.
  • Bachelor's Degree or higher in Engineering, Quality Management or a related technical field.
  • Industry certifications such as ASQ, Six Sigma, ISO13485 Lead Auditor are preferred.

Responsibilities

  • Quality Planning & Strategy: Lead the design and deployment of QMS processes to meet NPI objectives and customer requirements.
  • DFx & Technical Readiness: Drive DFx reviews and validation oversight (IQ/OQ/PQ) for smooth design-to-mass production transitions.
  • Launch Readiness: Manage launch readiness assessments and customer satisfaction surveys for health-tech sites.
  • Regulatory Oversight: Ensure conformance to ISO 13485, ANSI/ESD and other international regulations.
  • Performance Monitoring: Analyze data from audits and scorecards to identify gaps and drive corrective actions.
  • Global QMS Process Ownership: Develop and support key QMS processes to maintain regulatory compliance.
  • Process Deployment: Document and roll out global quality processes aligned with corporate initiatives.
  • Training & Capability Building: Educate sites on global procedures to build capable, long-term teams.

Skills

Quality Frameworks
NPI Quality Planning
Advanced Quality Tools
Validation & DFx
Performance Analytics

Education

Bachelor's Degree or higher in Engineering or Quality Management
Industry certifications (ASQ, Six Sigma, ISO13485 Lead Auditor)

Job description

Celestica is seeking a Senior Quality Manager to lead New Production Introduction (NPI) quality activities across HealthTech sites in Europe. You will own quality planning, DFx governance, and regulatory compliance to ensure smooth transitions from design to manufacturing.

The role focuses on driving launch readiness, performance analytics, and global QMS deployment, with a strong emphasis on DFx and validated processes to meet customer requirements.

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