Job Information
Endologix Inc Director, Quality Systems and Post Market Surveillance in Santa Rosa, California
Join our mission-driven Quality team as the Director, Quality Systems and Post Market Surveillance at Endologix!
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 trainingsupported by industry-leading clinical evidence. At Endologix, were 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 youre passionate about making a meaningful difference in healthcare, youll 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 whats 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:
Were looking for a Director, Quality Systems and Post Market Surveillance to join our mission-driven Quality team. In this role, youll be responsible for Quality Systems and Post Market Surveillance across the sites. This role leads and collaborates closely with RandD, 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.
WHAT YOU'LL DO:
- 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 qual ty 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.