Experteer Overview
In this role you will lead ISO 13485 QMS integration with local operations and act as the SME for quality systems. You will support audits, manage CAPAs and NCRs, and oversee environmental monitoring and cleanroom controls. You’ll align global quality strategies with site execution and communicate effectively with customers and regulators. You will influence sterile processing and release activities to ensure compliant, high-quality products.

Compensaciones / Incentivos
• Lead ISO 13485 QMS alignment with local facility procedures
• Serve as ISO 13485 SME and update/create quality documentation
• Support third-party and regulatory audits (ISO 13485, FDA, customers)
• Drive CAPA/NCR/excursion follow-up, root cause analysis, and closure
• Oversee cleanroom operations and regulatory-compliant production
• Manage external supplier testing and outsourced laboratory testing




• Oversee environmental validation activities and URS for environmental controls
• Monitor and approve sterilization reports; issue CoCs and Sterilization Certificates
• Coordinate shipping, release, and final product release to customers

Responsabilidades
• 10+ years in a technical Microbiology/Lab Management role in Medical Device
• Deep regulatory knowledge: ISO 13485, ISO 14644, FDA 21 CFR Part 820
• Strong background in sterilization and cleanroom validations
• Excellent communication with clients, teams, and regulators
• Fluent in English (written and spoken); Spanish preferred
• Leadership experience aligning global strategies with local execution

Requisitos principales
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📌 Quality Manager - Medical Device QMS and Controlled Environments (Valencia)
🏢 Celestica
📍 Valencia