Quality Manager: Medical Device QMS & Cleanroom Ops

Celestica Inc.; Valencia; On-site; EUR 70,000 - 100,000; Full time

Job summary

Celestica Inc. in Valencia, Spain, is seeking a Quality Manager to lead the Medical Device QMS and environmental controls.

You will align ISO 13485 procedures with local facility operations and serve as SME for the quality system, driving documentation updates and audit readiness. The role covers product release, supplier testing oversight, cleanroom validation, and CAPA management, with a focus on regulatory compliance, environmental validation, and clear communication with clients and

Qualifications

• Bachelor’s or Master’s in Microbiology, Biology or related science.
• 10+ years in a technical Microbiology/Lab Management role within Medical Device.
• Deep knowledge of ISO 13485, ISO-14644, FDA 21 CFR Part 820 and related standards.
• Experience with sterilization validations and cleanroom validations.
• Excellent communication with clients, internal teams, and regulatory bodies.

Responsibilities

• Lead the alignment of ISO13485 QMS with local facility procedures and ensure compliant transitions.
• Act as SME for ISO 13485; update QMS documentation and create new docs to align with regulations and customer requirements.
• Support third‑party and regulatory audits (Corporate, ISO13485, customers, FDA inspections).
• Drive CAPA/NCR/excursion/quality event follow-up and closure.
• Oversee cleanroom operations and ensure uninterrupted, compliant production.
• Manage external supplier testing and outsourced laboratory testing logistics.
• Provide guidance on environmental validation protocols and URS creation for environmental controls.
• Monitor critical systems quality parameters and calibrations, and review related reports.
• Review pest control and housekeeping trends to maintain controlled environments.
• Coordinate product release and shipping quality inspections to customers.

Skills

Leadership

Audit readiness

Regulatory knowledge

Communication

English fluency

GxP/Quality Systems

Education

Bachelor’s or Master’s in Microbiology/ Biology

Job description

Celestica Inc. in Valencia, Spain, is seeking a Quality Manager to lead the Medical Device QMS and environmental controls.

You will align ISO 13485 procedures with local facility operations and serve as SME for the quality system, driving documentation updates and audit readiness. The role covers product release, supplier testing oversight, cleanroom validation, and CAPA management, with a focus on regulatory compliance, environmental validation, and clear communication with clients and