Quality Systems and Compliance Audit Lead

About the role

The Quality Systems and Compliance Audit Lead will drive internal audit processes, ensure audit readiness, and maintain compliance with Quality Management System and regulatory requirements for medical devices.

Key responsibilities

• Conduct internal audits of the Quality System to verify compliance with QSR/GMP, ISO standards, and company policies.
• Lead audit teams, manage corrective and preventive actions, and document audit findings.
• Support external audits, accompany auditors, and ensure effective response to observations.
• Maintain audit records, monitor corrective action effectiveness, and communicate compliance metrics to site management.

Required profile

• BS in science, engineering, or business with 4‑6 years of experience in quality, regulatory compliance, or related activities.
• Experience in the medical device or pharmaceutical industry.
• Strong analytical and communication skills in English and Spanish.
• Ability to lead audit teams and interact with regulatory agencies.

Required skills

• Knowledge of QSR, GMP, ISO, and GLP audit standards.
• Audit planning, execution, and reporting.
• Lead auditor certification (preferred).
• Proficiency with audit management software and documentation tools.