Senior NPI Quality Leader: Global DFx & Compliance

Cecotec; Valencia; On-site; EUR 90,000 - 130,000; Full time

Job summary

Celestica is seeking a Senior Quality Manager focused on New Production Introduction (NPI) to drive quality strategy across healthtech sites in Europe. You will lead QMS development, DFx validation planning, and launch readiness activities to ensure smooth transitions from design to high‑volume production.

The role requires deep experience in ISO13485, DFx, and global QA processes, with a track record of leading cross-functional teams and regulatory compliance.

Qualifications

• Expert-level knowledge of ISO 13485, 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-specific quality objectives.
• Mastery of core quality methodologies: FMEA, 8D, CCB, MQS.
• Validation & DFx: IQ/OQ/PQ strategies for design to mass production.
• Ability to assess quality performance data to establish metrics and improvement strategies.

Responsibilities

• Lead design and deployment of QMS processes to meet NPI objectives and customer requirements.
• Drive DFx reviews and validation oversight for seamless design-to-mass-production transitions.
• Manage launch readiness, monthly operations reviews, and customer satisfaction surveys at HealthTech sites.
• Ensure site conformance to international regs and customer certifications (ISO 13485, ANSI/ESD).
• Analyze data from audits and scorecards; communicate action plans to stakeholders.

Skills

Quality Frameworks

NPI Quality Planning

Advanced Quality Tools

Validation & DFx

Performance Analytics

Education

Bachelor's in Engineering/Quality

Industry certifications (ASQ/Six Sigma)

Job description

Celestica is seeking a Senior Quality Manager focused on New Production Introduction (NPI) to drive quality strategy across healthtech sites in Europe. You will lead QMS development, DFx validation planning, and launch readiness activities to ensure smooth transitions from design to high‑volume production.

The role requires deep experience in ISO13485, DFx, and global QA processes, with a track record of leading cross-functional teams and regulatory compliance.