Quality Manager: Medical Device QMS & Cleanroom

Domestiko.Com; Valencia; Vor Ort; EUR 85.000 - 115.000; Vollzeit

Zusammenfassung

Celestica in Valencia, Spain, seeks a Quality Manager for Medical Device QMS and controlled environments to lead ISO 13485 alignment with local facilities and drive audits and CAPA processes.

You will oversee cleanroom operations, environmental monitoring, supplier testing, and validation activities, interfacing with customers and regulatory bodies to ensure compliant, robust quality systems.

Qualifikationen

• Experience with ISO 13485 and regulatory requirements.
• Proven track record in microbiology or lab management in Medical Device.
• Strong leadership and cross-functional collaboration skills.

Aufgaben

• Lead ISO 13485 QMS integration with local facilities.
• Manage audits and regulatory inspections.
• Drive CAPAs, NCRs, excursions and quality events to closure.
• Oversee environmental monitoring, cleanroom controls, and validations.

Kenntnisse

ISO 13485 knowledge

Audit readiness

CAPA management

Leadership

English proficiency

Ausbildung

Bachelor's or Master's in Microbiology/Biology

Tools

Quality systems tools

Jobbeschreibung

Celestica in Valencia, Spain, seeks a Quality Manager for Medical Device QMS and controlled environments to lead ISO 13485 alignment with local facilities and drive audits and CAPA processes.

You will oversee cleanroom operations, environmental monitoring, supplier testing, and validation activities, interfacing with customers and regulatory bodies to ensure compliant, robust quality systems.