Senior NPI Quality & Launch Manager (HealthTech)

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

Job summary

Celestica is seeking a Senior Quality Manager - NPI Focus to lead QMS deployment, DFx reviews, and regulatory compliance across HealthTech sites in Europe. You will drive NPI quality readiness, define processes, and enable seamless transitions from design to mass production.

The role demands deep expertise in ISO 13485, 21 CFR 820, and robust analytics to monitor performance, support launch readiness, and mentor global teams in executing long-term quality initiatives.

Qualifications

• Expert knowledge of ISO 13485 and 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards.
• Deep proficiency in defining critical quality business processes, tools and system applications for site-level and customer objectives.
• Mastery of FMEA, 8D, CCB protocols and MQS to drive quality improvements.

Responsibilities

• Quality Planning & Strategy: design and deploy QMS processes to meet NPI objectives and customer requirements.
• DFx & Technical Readiness: drive DFx reviews and validation strategies (IQ, OQ, PQ) for smooth design-to-mass production transitions.
• Launch Readiness: manage launch readiness, monthly operations reviews and customer satisfaction surveys.
• Regulatory Oversight: ensure conformance to ISO 13485 and other relevant regulations and certifications.
• Performance Monitoring: analyze data from audits and scorecards to identify gaps and drive action plans.
• Global QMS Process Ownership: develop and support key QMS processes for regulatory compliance and risk mitigation.
• Process Deployment: document and deploy global quality processes across sites in line with corporate initiatives.
• Training & Capability Building: educate sites on global procedures to build independent quality teams.

Skills

Quality Frameworks

NPI Quality Planning

Advanced Quality Tools

Validation & DFx

Performance Analytics

Education

Bachelor's degree or higher in Engineering/Quality Management

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

Job description

Celestica is seeking a Senior Quality Manager - NPI Focus to lead QMS deployment, DFx reviews, and regulatory compliance across HealthTech sites in Europe. You will drive NPI quality readiness, define processes, and enable seamless transitions from design to mass production.

The role demands deep expertise in ISO 13485, 21 CFR 820, and robust analytics to monitor performance, support launch readiness, and mentor global teams in executing long-term quality initiatives.