Quality Manager, Medical Device QMS & Cleanroom Compliance

Domestiko.Com; Valencia; On-site; EUR 70,000 - 90,000; Full time

Job summary

Celestica, Inc. is seeking a Quality Manager to lead the Medical Device QMS alignment with ISO 13485 across Europe, ensuring regulatory compliance and seamless operations. The role includes updating quality documentation, supporting audits, and driving CAPA closures within controlled environments.

The successful candidate will oversee cleanroom operations, monitor critical systems, and coordinate environmental validation activities with external suppliers and internal teams.

Qualifications

• Bachelor's or Master's degree in Microbiology, Biology or a closely related science.
• 10+ years of proven, technical Microbiology/Lab Management in Medical Device.
• Deep regulatory knowledge: ISO 13485, ISO 14644, FDA 21 CFR Part 820.
• Strong background in sterilization and cleanroom validations.
• Fluent English; Spanish preferred for local collaboration.

Responsibilities

• Lead ISO 13485 QMS alignment across global and local procedures.
• Act as SME for ISO 13485; update docs and create compliant records.
• Support audits (corporate, ISO 13485, customer, FDA) with technical input.
• Drive CAPA/NCR/Excursion closure and root-cause analysis.
• Oversee cleanroom operations and controlled environments.
• Manage external supplier testing and environmental monitoring.
• Provide training and oversight for environmental validation URS/Protocols.

Skills

Quality management

Regulatory knowledge

Leadership

Audit readiness

Education

Bachelor's or Master's Degree in Microbiology or Biology

Tools

Sterilization validations

Cleanroom validations

Job description

Celestica, Inc. is seeking a Quality Manager to lead the Medical Device QMS alignment with ISO 13485 across Europe, ensuring regulatory compliance and seamless operations. The role includes updating quality documentation, supporting audits, and driving CAPA closures within controlled environments.

The successful candidate will oversee cleanroom operations, monitor critical systems, and coordinate environmental validation activities with external suppliers and internal teams.