Senior Quality Manager, Medical Device QMS & Cleanrooms

Sharp-Consultores; Valencia; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Celestica in Valencia, Spain seeks a Quality Manager for Medical Device QMS and cleanroom environments. You will align ISO 13485 QMS with local procedures, manage documentation and support audits.

You will oversee cleanroom operations, environmental monitoring, sterilization controls, CAPAs, supplier testing, and regulatory compliance, interfacing with customers and regulators. Fluent English required; Spanish preferred.

Formación

• Education requirement: Bachelor’s or Master’s in Microbiology, Biology or related field.
• 10+ years of proven experience in a technical Microbiology/Lab Management role within Medical Device industry.
• Deep regulatory knowledge with ISO 13485, ISO-14644, FDA 21 CFR Part 820 and other standards.
• Strong technical background in sterilization validations, cleanroom validations, and microbiological lab controls.
• Leadership skills to align global strategies with local execution and communicate with clients and regulators.
• Fluent in English (written and spoken); Spanish preferred.

Responsabilidades

• Lead ISO 13485 QMS alignment and update documentation.
• Support third-party and regulatory audits (ISO 13485, FDA inspections).
• Drive CAPAs, NCRs, excursions, and other quality events to closure.
• Oversee cleanroom and facility operations for compliant production.
• Manage external supplier testing and environmental monitoring programs.
• Monitor critical systems and calibration processes to ensure compliance.

Conocimientos

Leadership

Communication

English proficiency

Regulatory knowledge

Educación

Bachelor's or Master's in Microbiology/Biology

Herramientas

Sterilization validations

Cleanroom validations

Microbiological lab controls

Descripción del empleo

Celestica in Valencia, Spain seeks a Quality Manager for Medical Device QMS and cleanroom environments. You will align ISO 13485 QMS with local procedures, manage documentation and support audits.

You will oversee cleanroom operations, environmental monitoring, sterilization controls, CAPAs, supplier testing, and regulatory compliance, interfacing with customers and regulators. Fluent English required; Spanish preferred.