ISO 13485 Quality Lead – Medical Device Compliance

Maria José Sánchez Odontología Avanzada; Valencia; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

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Zusammenfassung

Celestica is seeking a Quality Manager to lead Medical Device QMS and environmental controls in Valencia. You will align ISO 13485 processes with local procedures, serve as the QA SME, update documentation, and support audits by customers and regulators.

The role requires extensive microbiology/lab management experience in a regulated medical device setting, with strong leadership and communication skills to interface with clients and regulators globally.

Qualifikationen

• Bachelor's or Master's degree in Microbiology, Biology, or a closely related scientific discipline.
• 10+ years of proven, extensive experience in a highly technical Microbiology/Lab Management role within Medical Device industry.
• Deep regulatory knowledge of ISO 13485, ISO-14644, FDA 21 CFR Part 820, and other relevant international standards.

Aufgaben

• Lead ISO13485 QMS alignment and integration with local procedures.
• Serve as SME for ISO 13485; update Quality System Documentation and create new docs.
• Provide audit readiness support during third-party and regulatory audits (Corporate, ISO 13485, customers, FDA).
• Drive CAPA, NCR, Excursion, and Quality Event closures.

Kenntnisse

Leadership

Communication

Fluent English

Ausbildung

Bachelor's or Master's in Microbiology/Biology

Jobbeschreibung

Celestica is seeking a Quality Manager to lead Medical Device QMS and environmental controls in Valencia. You will align ISO 13485 processes with local procedures, serve as the QA SME, update documentation, and support audits by customers and regulators.

The role requires extensive microbiology/lab management experience in a regulated medical device setting, with strong leadership and communication skills to interface with clients and regulators globally.