Senior Quality Leader - ISO 13485 & Cleanroom Compliance

Barceló Arrendamientos Hoteleros, S.L.; Valencia; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Celestica is seeking a Quality Manager for Medical Device QMS and controlled environments in Spain. Lead ISO 13485 alignment, update documentation, and support audits. Manage CAPAs, NCRs, and critical systems, while overseeing cleanrooms and supplier testing to ensure compliant production and release to customers.

Requirements include 10+ years in Microbiology/Lab Management in Medical Devices, plus strong regulatory knowledge and leadership. Fluency in English; Spanish preferred.

Formación

• Education: Bachelor's or Master's in Microbiology, Biology or related field.
• 10+ years in a highly 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.
• Leadership and strong cross‑functional communication skills.

Responsabilidades

• Lead ISO 13485 QMS alignment with local facility procedures.
• Act as SME for ISO 13485; update docs and align with regulations.
• Support third‑party and regulatory audits (ISO13485, FDA inspections).
• Drive CAPAs, NCRs, excursions and quality events to closure.
• Oversee cleanrooms, production quality and external supplier testing.
• Provide guidance for Environmental Validation and URS creation.
• Monitor critical systems, calibrations and pest control trends.
• Review sterilization reports and issue CoCs to customers.
• Manage shipping, release processes and final product release to customers.

Conocimientos

Leadership

Communication

Global alignment

Audits

Regulatory understanding

Educación

Bachelor's or Master's in Microbiology/Biology

Descripción del empleo

Celestica is seeking a Quality Manager for Medical Device QMS and controlled environments in Spain. Lead ISO 13485 alignment, update documentation, and support audits. Manage CAPAs, NCRs, and critical systems, while overseeing cleanrooms and supplier testing to ensure compliant production and release to customers.

Requirements include 10+ years in Microbiology/Lab Management in Medical Devices, plus strong regulatory knowledge and leadership. Fluency in English; Spanish preferred.