Staff Auditor, Audit Readiness & Regulatory Intelligence

Overview

Join our innovative, mission-driven Quality team as a Staff Auditor, Audit Readiness & Regulatory Intelligence at Endologix!

Join our innovative, mission-driven Quality team as a Staff Auditor, Audit Readiness & Regulatory Intelligence at Endologix!

Endologix LLC is a California-based global medical device company dedicated to improving patients’ lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training—supported by industry-leading clinical evidence.

At Endologix, we’re driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health. What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our core values guide how we operate. As for our people?

We empower them with the tools, trust, and continuous learning they need to grow. If you’re passionate about making a meaningful difference in healthcare, you’ll find purpose and belonging here.

The Staff Auditor, Audit Readiness & Regulatory Intelligence is a senior individual contributor responsible for leading the execution and continued maturation of the company’s risk-based internal audit program, coordinating external audit and inspection readiness, and translating emerging regulatory requirements into actionable Quality System insight. Reporting to the Director, Audit, Supplier Quality & Applied AI Architecture, this role manages the enterprise audit schedule, leads complex Quality Management System audits, supports regulatory and certification audits from preparation through response and lessons learned, and publishes a concise monthly regulatory intelligence newsletter.

The role also partners with the Director and cross-functional stakeholders to design, test, govern, and improve human-in-the-loop AI agents supporting audit planning, readiness, evidence review, regulatory intelligence, and risk detection. The Principal Auditor serves as a trusted subject matter expert and cross-functional leader without direct people-management responsibility.

WHAT YOU'LL DO:

• Develop, maintain, and execute the risk-based internal audit universe and annual audit schedule in alignment with the audit strategy and priorities established by the Director, leveraging applicable requirements, process and product risk, prior findings, CAPA effectiveness, external audit outcomes, organizational changes, performance trends, and emerging regulatory intelligence to proactively identify priorities, strengthen compliance, and support continuous organizational improvement.
• Plan, lead, document, and close complex internal audits across Quality System and operational processes, ensuring clear criteria, auditor independence, objective-evidence sampling, defensible conclusions, timely reporting, and appropriate escalation of systemic issues while fostering transparency, accountability, and effective cross-functional engagement.
• Coordinate trained auditors and subject matter experts assigned to the audit program, including agenda development, auditor assignments, conflict-of-interest review, audit preparation, execution expectations, report quality, and follow-up, promoting a collaborative and solutions-oriented audit culture without direct supervisory responsibility.
• Monitor audit-plan execution, overdue…