Senior NPI Quality & Compliance Lead

Colegio De Economistas De Valencia - Coev; Valencia; On-site; EUR 90,000 - 120,000; Full time

Job summary

Celestica, Valencia site, seeks a Senior Quality Manager focused on New Production Introduction (NPI). You will lead the design and deployment of QMS processes to meet customer requirements and regulatory standards across global sites.

Responsibilities include DFx reviews, IQ/OQ/PQ validation oversight, launch readiness, and data-driven performance analysis to drive operational excellence in HealthTech environments.

Qualifications

• Bachelor's degree in Engineering, Quality Management or related field.
• 15+ years in Quality Management with NPI, manufacturing scale‑up, and global QMS deployment.
• Expert knowledge of ISO 13485, 21 CFR 820, and ANSI/ISO/ESD standards.
• Proven ability to lead global QMS deployments and regulatory compliance.
• Industry certifications (ASQ, Six Sigma, ISO13485 Lead Auditor) preferred.

Responsibilities

• Lead Quality Planning & Strategy to meet NPI objectives and customer requirements.
• Drive DFx reviews and oversight on validation strategies (IQ/OQ/PQ).
• Manage launch readiness, Monthly Operations Reviews, and customer surveys.
• Ensure regulatory conformance and certifications across sites (ISO 13485, etc).
• Analyze performance data and communicate action plans to stakeholders.

Skills

ISO 13485

21 CFR 820 (QMSR)

DFx & NPI Quality Planning

FMEA

8D Methodology

CCB processes

MQS

Regulatory knowledge

Leadership

Education

Bachelor's degree in Engineering or Quality Management

ASQ/Six Sigma or ISO13485 Lead Auditor certifications preferred

Job description

Celestica, Valencia site, seeks a Senior Quality Manager focused on New Production Introduction (NPI). You will lead the design and deployment of QMS processes to meet customer requirements and regulatory standards across global sites.

Responsibilities include DFx reviews, IQ/OQ/PQ validation oversight, launch readiness, and data-driven performance analysis to drive operational excellence in HealthTech environments.