Director of Audit, Supplier Quality, & Applied AI Architecture

Join our Compliance team as the Director of Audit, Supplier Quality & Applied AI Architecture!

WHO WE ARE:

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.

Our Core Values are the guiding principles informing our choices and actions, because our customers and patients depend on us:

• Patient Outcomes Drive Us: We improve lives with every advancement we deliver.
• Integrity Defines Us: We do what’s right, stay transparent, prioritize quality, and own our actions.
• Innovation Advances Us: We stay curious, adaptable, and push boundaries.
• Boldness Propels Us: We take smart risks and are unafraid in our pursuit of excellence.
• Collaboration Unites Us: We partner across teams and with physicians to drive exceptional results.

ABOUT THE ROLE:

The Director of Audit, Supplier Quality, & Applied AI Architecture is a senior leadership role responsible for establishing, maintaining, and continuously improving a comprehensive audit and supplier quality program in compliance with ISO 13485, FDA Quality Management System Regulation (QMSR / 21 CFR Part 820), and global regulatory requirements (e.g., EU MDR, MDSAP, Health Canada, PMDA, TGA).

This role provides independent assurance of Quality Management System (QMS) effectiveness, ensures robust oversight of the supply chain quality, leads external audit readiness and execution, and drives regulatory intelligence activities to proactively adapt the organization to evolving global requirements.

This role operates at a corporate level to define and govern the application of AI within regulated processes, establishing Applied AI architecture that improves the decision quality, standardizes review practices across QA, RA, and R&D, and proactively identifies technical, regulatory, and operational risks before documentation is finalized or enters controlled systems.

WHAT YOU'LL DO:

 Internal Audit Leadership (ISO 13485 Clause 8.2.4)

• Develop and execute a risk-based global internal audit strategy aligned with ISO 13485, QMSR, and MDSAP.
• Conduct and oversee audits across functions, sites, and processes to assess:
• QMS effectiveness
• Regulatory compliance
• Risk management integration (ISO 14971)
• Ensure effective closure of audit findings through CAPA, focused on sustainable, systemic corrective actions that strengthen quality outcomes and patient safety.
• Provide independent, executive-level reporting and insights to senior leadership and Management Review, fostering transparency and informed decision making.
• Leverage AI-enabled systems to improve consistency of audit evaluation and detection of high-risk issues.

External Audits & Inspection Management

• Lead organizational readiness for and execution of external audits and inspections, including:
• FDA inspections
• Notified Body audits (EU MDR)
• MDSAP audits
• Other global regulatory authority audits
• Serve as the primary point of contact and host during external audits.
• Direct and coordinate pre-audit preparation, audit strategy, and subject matter expert alignment through strong cross-functional collaboration.
• Ensure high-quality, compliant, and timely responses to audit observations (e.g., FDA 483s, nonconformities).
• Lead inspection readiness programs, including mock audits and gap assessments.
• Translate inspection outcomes and regulatory trends into systemic improvements and proactive risk mitigation across the organization.

Supplier Quality Management (ISO 13485 Clause 7.4)

• Establish and lead a global supplier quality program, including:
• Supplier qualification and onboarding
• Risk-based supplier classification
• Performance monitoring and scorecards
• Supplier auditing (on-site, remote, hybrid)
• Ensure compliance with purchasing controls and supplier quality agreements.
• Oversee supplier CAPAs and escalation processes.
• Partner cross-functionally to ensure supply chain risk mitigation and continuity, and consistent quality performance.
• Drive supplier performance improvement and development initiatives through standardized processes, meaningful metrics, and scalable programs.

Regulatory Intelligence & Compliance Strategy

• Establish and lead a regulatory intelligence capability to monitor, interpret, and communicate evolving global regulations and standards.
• Proactively assess impact of regulatory changes (e.g., QMSR transition, EU MDR updates, ISO revisions) on the QMS.
• Translate regulatory requirements into actionable strategies, policies, and procedures that support compliant and effective execution.
• Partner with Regulatory Affairs and Quality leadership to ensure ongoing compliance and strategic alignment.
• Support global market access by ensuring consistent application of regulatory expectations across audit and supplier practices.
• Leverage audit, supplier, and regulatory intelligence data to identify cross-functional trends and emerging risks and opportunities for continuous improvement

• Utilize AI-enabled systems to improve visibility, consistency, and early detection of risks across the documentation lifecycle.

Applied AI Architecture

• Define and govern the application of AI within regulated processes to improve decision quality, consistency, and risk identification across QA, RA, and R&D
• Establish and lead a standardized, AI-enabled review framework applied prior to documentation finalization, ensuring decisions are technically and regulatorily defensible before entering controlled systems.
• Drive adoption of AI-enabled systems to:
• • Improve consistency of decision making
  • Reduce reliance on individual expertise
  • Increase visibility into enterprise-level risk
  • Improve understanding and application of regulatory expectations
• Ensure AI-enabled capabilities are deployed in alignment with regulatory expectations using risk-based validation and controlled implementation approaches.
• Monitor performances of AI-enabled systems through defined feedback loops, consistency testing and user interaction metrics to continuous improvement and drift detection.
• Monitor industry trends, regulatory expectations, and emerging best practices for AI in regulated environments to encourage responsible innovation and alignment with evolving standards.

Leadership & Organizational Development

• Build and lead a high-performing team across internal audit, supplier quality, and external audit readiness.
• Develop organizational capabilities in:
  • Risk-based auditing (ISO 19011)
  • Regulatory compliance
  • Inspection preparedness
• Improve the level of understanding and application of QA standards, risk evaluation, and regulatory alignment across the organization.
• Foster a culture of accountability, transparency, collaboration, and continuous improvement.

Metrics, Reporting & Executive Communication

• Define and monitor KPIs, including:
  • Audit effectiveness and closure timelines
  • Inspection outcomes
  • Supplier quality performance
  • Regulatory change implementation status
• Provide regular updates to executive leadership and Management Review.
• Translate data and performance metrics into risk-based insights and prioritized actions to support timely, informed decision making.
• Leverage data analytics and AI-enabled systems to enhance visibility, consistency, and early identification of emerging risks.

Travel Requirements

• Approximately 25-35%, aligned to high-risk suppliers, critical audits, and regulatory inspections based on business needs.

WHAT YOU'LL BRING:

Education:

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).

Experience:

• 15+ years in Quality/Regulatory roles within the medical device industry.
• 10+ years of leadership experience in global or multi-site environments.

Skills/Competencies:

Required Expertise

• Deep knowledge of:
• ISO 13485:2016
• FDA 21 CFR Part 820 / QMSR
• MDSAP audit model
• EU MDR and global regulatory frameworks
• Strong experience in:
• Internal and external audit leadership
• Regulatory inspections and responses
• Supplier quality systems
• Regulatory intelligence or policy interpretation
• Proven ability to implement risk-based QMS strategies.

Preferred Certifications

• ASQ Certified Quality Auditor (CQA)
• ISO 13485 / MDSAP Lead Auditor
• Six Sigma certification (preferred)

Key Competencies

• Strategic leadership and executive presence.
• Deep regulatory and compliance expertise.
• Strong audit and inspection management capability.
• Risk-based thinking and decision-making.
• Influencing across functions and geographies.
• Excellent communication and stakeholder management.

WHAT WE OFFER:

At Endologix, we know that great work starts with great people — and people do their best when they feel valued and supported. That’s why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You’ll be part of a team that’s making a real impact on patients’ lives. When you join us, you’re not just taking a job, you’re building a meaningful career with a team that’s invested in your success.

The compensation package includes:

• Competitive Base Salary
• Discretionary bonus
• Equity participation as approved by Board of Directors (4-year vesting schedule)
• Comprehensive health, dental, and vision insurance plans
• Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
• Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
• 401(k) retirement plan with company match

Plus:

• Flexible work arrangements, such as hybrid or remote work for many of our positions
• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends

OUR COMMITMENT TO EQUAL OPPORTUNITY & VETERAN INCLUSION:

Endologix LLC is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor, Endologix LLC is committed to taking affirmative action to recruit, employ, and advance in employment qualified individuals with disabilities and protected veterans.