Director, Quality Systems and Post Market Surveillance

Endologix

1d•$200,000 - $230,000•Hybrid

About The Position

We’re looking for a Director, Quality Systems and Post Market Surveillance to join our mission-driven Quality team. In this role, you’ll be responsible for Quality Systems and Post Market Surveillance across the sites. This role leads and collaborates closely with R&D, Manufacturing, Supply Chain, Quality, Regulatory Affairs, and other functions within the company. In addition, this role will regularly interface with external regulatory agencies, EU Competent Authorities and Notified Bodies.

Requirements

Bachelor’s degree in a technical discipline, required.
Minimum 5 years of progressive leadership experience in Quality in the Medical Device sector, preferably in Class III devices.
Demonstrated experience and success in the application of Quality Management principles.
Experience in development of Quality strategies and effective implementation.
Demonstrated working knowledge in application of US and International Medical Device regulations and standards, such 21 CFR 7, 803, 806, EU Medical Device Regulation, Medical Device Single Audit Program (MDSAP).
Excellent analytical and decision-making skills.
Experience in a fast-paced remedial environment leading to rapid growth.
Demonstrated experience in communicating successfully with regulatory agencies such as: FDA, PMDA, MHLW, EU Competent Authorities and Notified Bodies.
Patient-focused communicator and people leader with strong written and verbal communication skills, able to clearly translate complex Quality concepts while motivating and developing high-performing teams.
Change leader grounded in integrity and collaboration, with the ability to drive adoption of new processes and systems through education, influence, thoughtful negotiation, and cross-functional partnership.
Innovative and bold technical and managerial leader with a proven track record of recruiting, retaining, and developing strong teams, consistently improving performance while maintaining the highest standards of quality, compliance, and accountability.
Strategic mentor and coach who invests in people development, aligns performance with organizational goals, and builds a culture of trust, ownership, and continuous improvement.
Results-driven decision maker who uses data, KPIs, and sound judgment to guide teams toward outcomes that advance patient safety, product quality, and business excellence.

Nice To Haves

Master’s degree preferable.
ASQ Certification in any of the Quality Disciplines strongly desired.
Training on regulated industry quality management desired.

Responsibilities

Drives patient outcomes by developing and executing organizational strategies that ensure QWS requirements, regulatory obligations, and applicable standards are consistently met, supporting safe and effective products.
Leads with integrity by providing strong, transparent leadership to the Quality Systems and Post Market Surveillance teams, prioritizing quality, accountability, and compliance in all decisions.
Advances innovation by championing effective problem-resolution methodologies and continuously improving Standard Operating Procedures in collaboration with cross-functional partners.
Demonstrates boldness through proactive identification of system and process improvements, developing Quality plans that support both system and product advancement.
Strengthens collaboration by partnering across functions to provide Quality support for projects, align priorities, and drive exceptional business and patient-focused results.
Builds sustainable teams by creating and deploying an organizational staffing model that responds to evolving business needs while mentoring and coaching team members through performance objectives, development plans, and ongoing feedback.
Measures what matters by developing meaningful KPIs and routine reporting to ensure transparency, informed decision-making, and continuous improvement.
Leads by example by planning, scheduling, and completing projects that support company objectives and the growth and success of employees and direct reports.
Represents the quality function with confidence and professionalism, positively navigating challenges and reinforcing trust across the organization.
Performs additional duties as assigned, contributing flexibly and responsibly to broader organizational goals.
Supports global collaboration through travel to Endologix manufacturing sites in California and domestic and international partner locations, up to 30% of the time.

Benefits

Base salary of $200,000/yr-$230,000/yr
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
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