Senior QMS Leader - Medical Devices & ISO 13485

Sanitas; Valencia; On-site; EUR 90,000 - 120,000; Full time

Job summary

Celestica, Inc. seeks a Quality Manager for Medical Device QMS and Clean Environments in Valencia, Spain. You will align ISO 13485 procedures with local processes, act as SME for the QMS, and support audits across corporate, regulatory, and customer programs.

You will drive CAPAs, NCRs, and quality events to closure, oversee cleanroom operations, monitor critical systems, and ensure controlled environments meet regulatory and customer expectations.

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, or closely related field.
• 10+ years in a technical Microbiology/Lab Management role in Medical Device industry.
• Deep understanding of ISO 13485, ISO-14644, FDA 21 CFR Part 820 and other standards.

Responsibilities

• Lead ISO 13485 alignment of QMS procedures with local facility procedures.
• Act as SME for ISO 13485; update QMS documents and create new ones as required.
• Support audits (third-party, regulatory, customer, FDA) with technical expertise.
• Drive CAPAs, NCRs, excursions, and quality events to closure.
• Oversee cleanroom and factory operations to ensure compliant production.
• Manage external supplier testing for cleanroom and outsourced lab testing.

Skills

Leadership

Quality management

Auditing

Regulatory knowledge

English fluency

Education

Bachelor’s or Master’s in Microbiology/related

Job description

Celestica, Inc. seeks a Quality Manager for Medical Device QMS and Clean Environments in Valencia, Spain. You will align ISO 13485 procedures with local processes, act as SME for the QMS, and support audits across corporate, regulatory, and customer programs.

You will drive CAPAs, NCRs, and quality events to closure, oversee cleanroom operations, monitor critical systems, and ensure controlled environments meet regulatory and customer expectations.