NPI Quality Leader HealthTech DFx Expert

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

Job summary

Celestica is seeking a Senior Quality Manager with an NPI focus to lead the design and deployment of quality management systems across HealthTech sites. You will drive DFx reviews, oversee validation (IQ/OQ/PQ), and manage launch readiness and customer satisfaction programs.

The role requires extensive experience in ISO 13485 and related standards, plus a track record of data-driven quality improvements and cross-site collaboration. Global QMS ownership and training responsibilities are included.

Qualifications

• 15+ years of progressive experience in Quality Management, with NPI, manufacturing scale-up and global QMS deployment.
• Experience leading QMS design, deployment, and regulatory compliance at HealthTech sites.
• Strong track record in DFx reviews and validation strategies (IQ/OQ/PQ).

Responsibilities

• Lead design and deployment of QMS processes and tools to meet NPI objectives and customer requirements.
• Drive DFx reviews and oversee validation strategies for smooth design-to-mass production transitions.
• Manage launch readiness assessments, Monthly Operations Reviews, and customer satisfaction surveys.
• Ensure site-wide conformance to international regulations and certifications (ISO 13485, ANSI/ESD).
• Analyze quality data from audits and scorecards to identify gaps and drive action plans.
• Develop and support global QMS processes to ensure regulatory compliance and risk mitigation.
• Document and deploy global quality processes aligned with corporate initiatives.
• Educate sites on procedures to build independent long-term quality teams.

Skills

Quality Management

NPI Experience

Regulatory Compliance

Data Analysis

DFx & Validation

FMEA & 8D Methodology

Education

Bachelor's or higher in Engineering or Quality Management

ASQ/ISO13485 Lead Auditor certifications preferred

Tools

FMEA

8D Problem Solving

CCB protocols

IQ/OQ/PQ validation

Job description

Celestica is seeking a Senior Quality Manager with an NPI focus to lead the design and deployment of quality management systems across HealthTech sites. You will drive DFx reviews, oversee validation (IQ/OQ/PQ), and manage launch readiness and customer satisfaction programs.

The role requires extensive experience in ISO 13485 and related standards, plus a track record of data-driven quality improvements and cross-site collaboration. Global QMS ownership and training responsibilities are included.