Join our dynamic Quality team at Endologix as a Manager, Quality! 

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.

ABOUT THE ROLE:

We’re looking for an experienced Manager, Quality to join our Quality team. In this role, you’ll manage daily activities for Quality Assurance, Quality Ops Engineering, Calibration and R&I, which will include performing QA and QC review of manufacturing records and inspections, checks, and tests of incoming materials, components used in the manufacture of medical devices and finished goods. The Manager will also ensure products meet specified requirements and work performed complies with cGMP/GDP policies and internal procedures, will be responsible for periodic environmental monitoring of clean room areas, ensure adequate resources are available to meet manufacturing demand and meet cost and timeliness quality metrics of the QA/QC/R&I departments, and will be responsible for reporting area metrics and continuous improvement of procedures and practices. 

WHAT YOU'LL DO:

• Supervise daily Receiving Inspection and Assembly Inspection tasks.
• Assign priorities and resources.
• Provide support to manufacturing to ensure daily workloads and deadlines are achieved.
• Hire and train QA/QC employees. Implement and enforce company policies and departmental procedures.
• Evaluate and review individual performance annually or as needed.
• Ensure a safe working environment and enforce safety rules and policies.
• Evaluate issues and make recommendations for corrective action to department manager.
• Work with Production and Quality Assurance Management to provide feedback to assemblers regarding accuracy of assembly procedures.
• Support resolution of issues at the supplier impacting product quality.
• Collaborate with the supplier quality to in the supplier qualification, approval and selection process.
• Participate in construction and/or revision of inspection procedures and protocols.
• Assist in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
• Assist in maintenance of Quality Systems including Internal Audits, CAPA, Complaints, and Non-conforming Material Reports.
• Coordinate calibration of all applicable equipment, tools, and fixtures.
• Support environmental monitoring of clean room areas.
• Lead receiving inspection test method validation activities.
• Ensure a safe working environment and enforce safety rules and policies.
• Evaluate issues and make recommendations for corrective action and improvement to department manager.
• Supervise and monitor attendance for QA/QC teams and maintain timekeeping activities.
• Identifies hazards and mitigates risks related to Endologix products, processes, and Quality System.
• Reports risks to executive management.
• Take site quality leadership responsibilities and establish partnership and collaboration with the stakeholder functions.

WHAT YOU'LL BRING:

Education:

• Bachelor's degree in Engineering from a four-year college or university; or related major preferred.

Experience:

• Ten years of relevant experience in a biomedical industry with a Bachelor's degree.
• 3-4 years of people management experience, including but not limited to hiring, performance management and coaching.

Skills/Competencies:

• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, MDSAP, and EU MDR requirements.
• Proven experience with design controls, risk management (ISO 14971), validation (process, software, equipment), and quality engineering principles.
• Demonstrated expertise in CAPA management, nonconformance investigations, root cause analysis, and continuous improvement.
• Hands-on experience with internal/external audits, regulatory inspections, and interactions with Notified Bodies.
• Solid understanding of medical device manufacturing processes, including sterilization, packaging, labeling, and cleanroom operations.
• Effective leadership skills with the ability to mentor, coach, and develop a high-performing team.
• Strong cross-functional collaboration skills with R&D, Manufacturing, Regulatory, Clinical, and Supply Chain partners.
• Excellent problem-solving and analytical abilities, including the use of statistical tools (SPC, DOE, Six Sigma).
• Clear and concise communication skills, both written and verbal, with the ability to prepare executive-level reporting and presentations.
• Business-minded approach, balancing compliance with operational and organizational objectives.

HOW YOU'LL SHOW UP:

All In: Bring full commitment to everything you do. Support one another, hold yourself accountable, and take ownership of your work. Move with urgency, deliver on your promises, and lead with boldness and passion.

Act with Integrity: Prioritize ethics and transparency in every decision. Earn trust by being honest, respectful, and dependable — working diligently to uphold the confidence of your colleagues, customers, and communities.

Tenacious: Meet challenges head-on with resilience and resolve. Stay focused, push through obstacles, and consistently look for solutions, not excuses.

Pioneering: Challenge the status quo and embrace innovation. Develop new ideas, test bold solutions, and pave the way for others — driving progress through curiosity and creativity.

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:

• Base salary of $135,000/yr-$175,000/yr
• Discretionary bonus
• Equity participation as approved by Board of Directors (4-year vesting schedule)
• Comprehensive health, dental, and vision insurance plans
• Generous PTO and holiday schedule
• 401(k) retirement plan with company match

Plus:

• Employee wellness initiatives and mental health support
• Collaborative and inclusive company culture focused on impact and innovation
• Opportunities for career growth and internal mobility

OUR COMMITMENT TO DIVERSITY & INCLUSION:

Endologix LLC.  is an Equal Opportunity 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.