Remote Lead Internal Auditor, QMS & Compliance

Agilent Technologies; Tramoyes; Sur place; EUR 51 000 - 80 000; Plein temps

Avantages offerts par ce poste

Remote work option

Résumé du poste

Agilent Technologies is seeking a Lead Internal Auditor to plan, lead, and execute risk-based audits in regulated medical devices and pharmaceutical settings. You will serve as a subject matter expert on quality systems and regulatory auditing, ensuring compliance with global regulations while driving continuous QMS improvement.

The role focuses on the regulated internal audit program with secondary support for inspection readiness activities, collaborating with Quality, Regulatory, and site

Qualifications

• Bachelor's degree in science, engineering, or related field required; advanced degree preferred.
• 8+ years’ experience in regulated quality systems, internal auditing, or regulatory compliance within pharmaceutical and/or medical device industries.
• 5+ years’ experience as a Lead Internal Auditor, including audit planning, execution, and auditor management; ISO 13485 Lead Auditor certification required.

Responsabilités

• Lead and conduct risk-based internal audits across pharmaceutical and medical device operations per the approved audit schedule.
• Serve as Lead Auditor for complex, cross-functional, and multi-site audits, overseeing planning, execution, reporting, and follow-up.
• Assess QMS compliance and effectiveness against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements; develop audit strategies and communicate findings.
• Identify systemic issues and drive continuous improvement initiatives across the QMS.
• Provide guidance on interpretation and application of regulatory and quality requirements while maintaining auditor independence.
• Train and coach sites on self-directed audits to support the Internal Audit Program with oversight.
• Support inspection readiness activities and_NOTIFIED Body audits, including readiness reviews and documentation preparation.

Connaissances

Quality systems

Internal auditing

Regulatory compliance

Risk assessment

Communication

Travel readiness

Formation

Bachelor's degree in science/engineering

Description du poste

Agilent Technologies is seeking a Lead Internal Auditor to plan, lead, and execute risk-based audits in regulated medical devices and pharmaceutical settings. You will serve as a subject matter expert on quality systems and regulatory auditing, ensuring compliance with global regulations while driving continuous QMS improvement.

The role focuses on the regulated internal audit program with secondary support for inspection readiness activities, collaborating with Quality, Regulatory, and site