Senior Quality Auditor: Audit Readiness & Regulatory Intelligence

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

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

401(k) with match

HSA/FSA available

Paid time off

Job summary

Endologix LLC is seeking a Staff Auditor to lead the risk-based internal audit program, coordinate external inspections, and translate regulatory requirements into practical Quality System actions.

The role partners with Regulatory Affairs, Quality Systems, and cross-functional teams to design, test, and improve human-in-the-loop AI agents supporting audit planning, readiness, and evidence review, while publishing a concise regulatory intelligence newsletter.

Qualifications

• Minimum 8 years of progressive experience in medical device QA, auditing, regulatory compliance, or Quality Systems.
• Current ISO 13485 Lead Auditor certification is required.
• Demonstrated knowledge of FDA QMSR, ISO 13485, EU MDR and experience translating changes into Quality System requirements.

Responsibilities

• Lead internal audits and coordinate external audit readiness across Quality System processes.
• Plan, execute, and close complex audits with risk-based prioritization and clear documentation.
• Develop and publish a monthly regulatory intelligence newsletter citing changes, impact, owners, and follow-up actions.
• Partner with cross-functional teams to design, test, govern, and improve AI agents supporting audit planning and readiness.
• Maintain audit schedules, track findings, and provide routine status, trends, and risk insights to leadership.
• Coordinate external audits and inspections, including SME preparation and evidence-room strategy, to ensure readiness.

Skills

Audit principles

Regulatory intelligence

Quality systems

AI in regulated work

Project management

Travel readiness

Education

Bachelor's degree in Engineering or related

Tools

FDA QMSR

EU MDR

ASQ certification

Job description

Endologix LLC is seeking a Staff Auditor to lead the risk-based internal audit program, coordinate external inspections, and translate regulatory requirements into practical Quality System actions.

The role partners with Regulatory Affairs, Quality Systems, and cross-functional teams to design, test, and improve human-in-the-loop AI agents supporting audit planning, readiness, and evidence review, while publishing a concise regulatory intelligence newsletter.