Senior Quality & Compliance Lead - Medical Devices

Ballesol Group; Valencia; On-site; EUR 90,000 - 130,000; Full time

Job summary

Celestica Valencia seeks a Quality Manager to lead ISO 13485 QMS alignment across global and local processes in a Medical Device environment.

You will oversee environmental monitoring, cleanroom controls, sterilization validations, CAPAs and audits, collaborating with internal teams and regulators to ensure compliant product delivery.

Fluent English is required; Spanish is a plus; extensive microbiology/quality systems background preferred.

Qualifications

• Education in microbiology or related scientific discipline.
• 10+ years in microbiology/lab/quality in Medical Device.
• Strong ISO 13485 knowledge and regulatory experience.
• Experience with cleanrooms, sterilization validation and environmental controls.
• Leadership to align global strategies with local execution.

Responsibilities

• Lead ISO 13485 QMS alignment with local procedures.
• Act as SME for QMS; update docs and guidance.
• Support audits (regulatory, ISO13485, customers, FDA).
• Drive CAPAs, NCRs, excursions and quality events.
• Oversee cleanroom operations and external supplier testing.
• Manage environmental monitoring and validation efforts.

Skills

ISO 13485

QMS Management

Audits

CAPA & NCR

Cleanroom ops

Environmental monitoring

Sterilization validation

Regulatory knowledge

English fluent

Education

Bachelor's or Master's in Microbiology/related

Job description

Celestica Valencia seeks a Quality Manager to lead ISO 13485 QMS alignment across global and local processes in a Medical Device environment.

You will oversee environmental monitoring, cleanroom controls, sterilization validations, CAPAs and audits, collaborating with internal teams and regulators to ensure compliant product delivery.

Fluent English is required; Spanish is a plus; extensive microbiology/quality systems background preferred.