Senior Quality Manager - NPI & DFx HealthTech

Accor; Vitoria; On-site; EUR 90,000 - 120,000; Full time

Job summary

Celestica seeks a Senior Quality Manager focused on New Production Introduction (NPI) for HealthTech sites in Europe. You will lead QMS deployment, DFx validation strategies (IQ/OQ/PQ), and regulatory oversight to ensure compliant, high-quality transitions from design to mass production.

You will drive launch readiness, performance analytics and global process ownership, partnering with multiple sites to build capable teams and robust quality systems across the lifecycle.

Qualifications

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

Responsibilities

• Lead the design and deployment of QMS processes and tools to meet NPI objectives and customer requirements.
• Drive DFx reviews and oversight on validation strategies (IQ/OQ/PQ) for smooth design-to-mass production transitions.
• Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys for site excellence.
• Ensure site-wide conformance to international regulations and customer certifications (ISO 13485, ANSI/ESD).
• Analyze quality data from audits and scorecards to identify gaps and implement corrective actions.
• Develop and maintain global QMS processes to ensure regulatory compliance and risk mitigation.

Skills

Quality Planning

NPI Quality

FMEA

8D Methodology

DFx

Education

Bachelor's Degree in Engineering

Tools

IQ/OQ/PQ

Audit Compliance

Customer Feedback

Job description

Celestica seeks a Senior Quality Manager focused on New Production Introduction (NPI) for HealthTech sites in Europe. You will lead QMS deployment, DFx validation strategies (IQ/OQ/PQ), and regulatory oversight to ensure compliant, high-quality transitions from design to mass production.

You will drive launch readiness, performance analytics and global process ownership, partnering with multiple sites to build capable teams and robust quality systems across the lifecycle.