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 Quality System audits to verify compliance with QSR/GMP, ISO standards and company policies.
• Lead audit teams, provide guidance, and manage corrective and preventive actions.
• Document audit findings, classify observations, and monitor effectiveness of corrective actions.
• Support external auditors and government agency inspections.
• Participate in the development of regulatory policies and stay current on regulatory changes.

Required profile

• BS in science, engineering, or business.
• 4‑6 years of experience in Quality, Regulatory Compliance, or related roles within medical devices or pharmaceuticals.
• Effective oral and written communication in English and Spanish.
• Ability to lead audit teams and interact with regulators.

Required skills

• Knowledge of QSR, GMP, ISO standards and GLP audit practices.
• Audit management and reporting.
• Problem‑solving techniques and corrective action implementation.
• Lead auditor certification (preferred).