Overview

In this role you will lead the general quality framework for NPI, aligning design-to-production transitions with customer requirements. You will own QMS deployment, DFx reviews, and launch readiness across HealthTech sites to ensure regulatory compliance and operational excellence. You will translate data from audits and scorecards into actionable improvements and build capable, independent quality teams. This position offers impact across global operations, shaping quality processes and readiness for new productions. You will work closely with cross-functional teams to drive compliant, high-quality product launches.

Responsabilidades

- Design and deploy QMS processes and tools to meet NPI objectives and customer requirements
- Lead DFx reviews and validation strategies (IQ/OQ/PQ) for smooth design-to-mass production transitions
- Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys




- Ensure site-wide conformance to ISO 13485, ANSI/ESD and other regulations
- Analyze quality data from customer scorecards, audits, and operations to identify gaps and drive action plans
- Own and deploy global quality processes (Audit Compliance, Customer Feedback)
- Educate sites on global procedures to build independent, high-functioning quality teams

Requisitos principales

- 15+ years in Quality Management with NPI, manufacturing scale-up, and global QMS deployment
- Bachelor in Engineering or related technical field; industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor)

- leadership
- cross-functional collaboration
- data-driven decision making
- ISO 13485
- 21 CFR 820
- ANSI/ISO/ESD

📌 Manager, Global Quality (Valencia)
🏢 Celestica
📍 Valencia