Global Quality Manager, Medical Devices & ISO 13485

Celestica; Valencia; On-site; EUR 110,000 - 150,000; Full time

Job summary

Celestica in Valencia, Spain seeks a senior Quality & Regulatory Manager to align ISO 13485 QMS with local procedures, lead regulatory compliance, and support audits. You will drive CAPAs, oversee cleanroom operations, and manage supplier testing to ensure uninterrupted, compliant production in a global medical device environment.

The role requires 10+ years in Microbiology/Lab Management within the Medical Device industry, strong regulatory knowledge, and excellent communication with regulators

Qualifications

• Bachelor’s or Master’s in Microbiology, Biology, or related discipline.
• 10+ years in a highly technical Microbiology/Lab Management role in Medical Device industry.
• Deep understanding of ISO 13485, ISO‑14644, FDA 21 CFR Part 820, and related standards.
• Strong background in sterilization validations, cleanroom validations, and microbiological lab controls.
• Excellent communication skills to interface with clients, internal teams, and regulators.
• Fluent in English for corporate alignment and audits; Spanish preferred.

Responsibilities

• Lead ISO13485 QMS alignment with local procedures and regulatory requirements.
• Act as SME for ISO 13485; update documentation and create new ones.
• Support third-party and regulatory audits (Corporate, ISO13485, customers, FDA).
• Drive CAPAs, NCRs, excursions, and quality events to closure.
• Oversee cleanroom operations and ensure compliant production.
• Manage external supplier testing and laboratory testing logistics.

Skills

QMS & ISO13485

Regulatory knowledge

Leadership

Communication

English fluency

Spanish language

Education

Bachelor's or Master's in Microbiology or related field

Tools

Sterilization validation

Cleanroom validation

Microbiology lab controls

Job description

Celestica in Valencia, Spain seeks a senior Quality & Regulatory Manager to align ISO 13485 QMS with local procedures, lead regulatory compliance, and support audits. You will drive CAPAs, oversee cleanroom operations, and manage supplier testing to ensure uninterrupted, compliant production in a global medical device environment.

The role requires 10+ years in Microbiology/Lab Management within the Medical Device industry, strong regulatory knowledge, and excellent communication with regulators