Quality Manager - Medical Devices & ISO 13485

Cronoshare.Com; Torrente, Gerona; Vor Ort; EUR 90.000 - 110.000; Vollzeit

Zusammenfassung

Celestica is seeking a Quality Manager for Medical Device QMS and cleanroom environments in Spain. The role requires extensive ISO 13485 expertise, regulatory knowledge, and leadership to align global strategies with local operations.

You will oversee audits, CAPA processes, and environmental validation across sterile environments. You will manage documentation, supplier testing, and biological monitoring while ensuring strict compliance with FDA/ISO standards.

Qualifikationen

• Bachelor's or Master’s degree in Microbiology, Biology or closely related field.
• 10+ years of proven, technical Microbiology/Lab Management experience in Medical Device sector.
• Deep knowledge of ISO 13485, ISO-14644, FDA 21 CFR Part 820 and related standards.
• Strong background in sterilization and cleanroom validations, microbiological controls.
• Experience aligning global strategies with local execution and regulatory audits.

Aufgaben

• Lead ISO 13485 QMS alignment with local facility procedures and ensure compliance.
• Act as SME for ISO 13485; update and create QMS documents for regulations and customer needs.
• Support third-party and regulatory audits (ISO 13485, FDA, customers).
• Drive CAPA/NCR/excursion/quality event investigations and closure.
• Oversee cleanroom operations and ensure compliant production.
• Manage external supplier testing and laboratory testing for cleanrooms.
• Provide guidance for environmental validation protocols, URS and reports.
• Oversee biological monitoring and sterilization certificates, shipping releases.

Kenntnisse

ISO 13485

QMS management

CAPA & NCR

Audit readiness

Cleanroom operations

Sterilization validation

Regulatory knowledge

Leadership

English fluency

Ausbildung

Microbiology degree

Jobbeschreibung

Celestica is seeking a Quality Manager for Medical Device QMS and cleanroom environments in Spain. The role requires extensive ISO 13485 expertise, regulatory knowledge, and leadership to align global strategies with local operations.

You will oversee audits, CAPA processes, and environmental validation across sterile environments. You will manage documentation, supplier testing, and biological monitoring while ensuring strict compliance with FDA/ISO standards.