Quality Manager — ISO 13485 & Cleanroom Excellence

Cronoshare.Com; Valencia; Presencial; EUR 80.000 - 120.000; Jornada completa

Descripción de la vacante

Celestica, Inc. is seeking a Quality Manager to lead the ISO 13485 QMS and ensure alignment between corporate and local procedures across Europe, with emphasis on controlled environments and regulatory compliance.

The role requires extensive microbiology and lab management experience in the medical device sector, strong leadership, and fluency in English. Spanish language skills are preferred. This position is based in Valencia, Spain.

Formación

• Bachelor's or Master's degree in Microbiology or related field.
• 10+ years in microbiology/lab management in Medical Device.
• Strong knowledge of ISO 13485, ISO-14644, FDA 21 CFR Part 820.
• Sterilization and cleanroom validation experience.
• Proven leadership and cross-functional collaboration.
• Fluent in English; Spanish preferred.

Responsabilidades

• Align ISO 13485 QMS with local facility procedures and corporate standards.
• Act as SME for ISO 13485; update docs and create new ones to meet regs and customer needs.
• Support audits (third-party, regulatory, FDA inspections) with technical expertise.
• Drive CAPAs, NCRs, excursions, and quality event closures.
• Oversee cleanroom operations and production to ensure compliant output.
• Manage external supplier testing and laboratory testing logistics.

Conocimientos

Quality leadership

Audits & regulatory

Cross-functional collaboration

Communication

Problem solving

Educación

Bachelor's or Master's in Microbiology

Descripción del empleo

Celestica, Inc. is seeking a Quality Manager to lead the ISO 13485 QMS and ensure alignment between corporate and local procedures across Europe, with emphasis on controlled environments and regulatory compliance.

The role requires extensive microbiology and lab management experience in the medical device sector, strong leadership, and fluency in English. Spanish language skills are preferred. This position is based in Valencia, Spain.