Global Quality Manager - Medical Device QMS & Cleanrooms

Celestica; Valencia; On-site; EUR 70,000 - 110,000; Full time

Job summary

Celestica in Valencia seeks a seasoned Quality Manager to lead the Medical Device QMS and controlled environments. You will align ISO procedures with local operations, oversee audits, CAPAs, and ensure regulatory readiness across the site.

The role requires 10+ years in a technical Microbiology/Lab/Quality leadership within medical devices, deep regulatory knowledge (ISO, FDA), and strong collaboration with global teams to uphold product quality and compliance.

Qualifications

• Bachelor’s or Master’s degree in microbiology, biology or related field.
• 10+ years of technical microbiology/lab management in medical devices.
• Deep understanding of ISO, FDA 21 CFR Part and international standards.
• Strong leadership and cross-cultural communication abilities.
• Fluent in English; Spanish preferred.

Responsibilities

• Lead ISO QMS procedures alignment with local facility procedures.
• Act as SME for ISO; update quality system documentation and align with customer requirements.
• Support third-party and regulatory audits; drive corrective actions and CAPAs.
• Oversee cleanroom operations, equipment calibrations, and environmental controls.
• Ensure compliance across production, supplier testing, and release processes.

Skills

Leadership

Communication

Quality management

Regulatory understanding

Education

Bachelor’s or Master’s Degree in Microbiology, Biology, or related

Tools

ISO Standards

FDA 21 CFR Part

Job description

Celestica in Valencia seeks a seasoned Quality Manager to lead the Medical Device QMS and controlled environments. You will align ISO procedures with local operations, oversee audits, CAPAs, and ensure regulatory readiness across the site.

The role requires 10+ years in a technical Microbiology/Lab/Quality leadership within medical devices, deep regulatory knowledge (ISO, FDA), and strong collaboration with global teams to uphold product quality and compliance.