Staff Auditor — Audit Readiness & Regulatory Intelligence

careersus-endologix; Santa Rosa (CA); On-site; USD 110,000 - 128,000; Full time

Benefits offered by this job

Base salary

Discretionary bonus

Equity participation

Health insurance

HSAs/FSAs

Generous PTO

401(k) match

Wellness programs

Recognition programs

Commuter benefits

Job summary

Endologix LLC, a California-based medical device company, seeks a Staff Auditor to lead risk-based internal audits, external audit readiness, and regulatory intelligence initiatives. You will partner with cross-functional teams to ensure robust audit programs and timely responses to regulatory changes.

This role emphasizes leveraging AI-enabled tools to enhance audit readiness and compliance across the organization.

Qualifications

• Minimum 8 years in medical device quality, auditing, regulatory compliance, or related QA/QMS roles.
• Lead Auditor certification or equivalent experience preferred.
• Experience with FDA QMSR, ISO 13485, EU MDR is required.
• Ability to translate regulatory changes into Quality System requirements.

Responsibilities

• Develop and maintain the internal audit universe and annual schedule aligned with strategy.
• Lead complex audits of Quality System and operational processes with objective evidence.
• Coordinate auditors, assign roles, and ensure timely, high-quality reports and follow-up.
• Monitor findings, trends, and risk insights for Leadership and Management Review.
• Lead external audit readiness activities for FDA, notified bodies, and other regulatory bodies.
• Publish monthly regulatory intelligence updates with clear owner, applicability, and action steps.

Skills

Internal audit

Regulatory intelligence

Audit planning

FDA QMSR

ISO 13485

Cross-functional collaboration

Education

Bachelor’s degree

Job description

Endologix LLC, a California-based medical device company, seeks a Staff Auditor to lead risk-based internal audits, external audit readiness, and regulatory intelligence initiatives. You will partner with cross-functional teams to ensure robust audit programs and timely responses to regulatory changes.

This role emphasizes leveraging AI-enabled tools to enhance audit readiness and compliance across the organization.