Position: Quality Assurance Technician

Department: Quality

Location: Santa Rosa, CA

WHO WE ARE:

Endologix LLC operates as a is a subsidiary of Rhevera Medical Holdings, LLC, a global medical device company focused on preserving and restoring the blood flow patients depend on. Our innovative vascular portfolio spans aortic repair, peripheral arterial disease, and thrombectomy, including the ALTO® Abdominal Stent Graft System, AFX®2 Endovascular AAA System, DETOUR™ System, and Pounce™ Thrombectomy System.

At Rhevera Medical, innovation is more than what we create. It’s how we think, collaborate, and move patient care forward. We’re building a mission-driven culture where your ideas matter, your growth is supported, and your work can make a meaningful difference.

Our Core Values guide the choices we make and the way we work, 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.

Ready to bring your ideas, experience, and passion to work that matters? Join us and help shape what’s next in vascular care.

Employment with Endologix LLC: Candidates applying for this position are applying for employment with Endologix LLC, which operates as is a Rhevera Medical company. Candidates for this role will not be employed, or jointly employed, by Rhevera Medical Holdings, LLC.

ABOUT THE ROLE:

The Quality Assurance Technician is responsible for supporting implantable medical device quality assurance, manufacturing, and R&D activities through execution of product quality control testing, administration of the calibration program, environmental monitoring of cleanrooms, and support of engineering testing activities. This role ensures that monitoring and measuring equipment, product acceptance testing, and environmental controls are performed in compliance with FDA QSR, ISO 13485, and internal quality system requirements.

WHAT YOU'LL DO:

• Calibration & Measurement System Management
  • Administer the site calibration program under QA management oversight, ensuring reliable and compliant measurement systems that support product quality and patient safety.
  • Maintain controlled inventory of monitoring and measuring equipment to ensure operational readiness and data integrity.
  • Coordinate calibration activities with approved external calibration providers.
  • Review and approve calibration certificates for accuracy, traceability, and compliance.
  • Identify, document, and escalate out‑of‑tolerance (OOT) conditions, supporting informed decision-making and continuous improvement.
  • Ensure calibration status is maintained for equipment used in QA, manufacturing, R&D, and post‑market activities.

• Product Lot Release & Quality Testing
  • Perform product acceptance and lot release testing in accordance with approved procedures.
  • Review, verify, and process product work orders and quality records with a high level of accuracy and accountability.
  • Ensure testing results meet defined acceptance criteria prior to product release, supporting safe and effective products for patients.
  • Document test results accurately and maintain traceable records that promote transparency and compliance.

• Engineering & Product Testing Support
  • Support Engineering with product testing, verification, and validation and continuous improvement initiatives as required.
  • Ensure test equipment used for engineering activities is properly calibrated and qualified.
  • Assist with data collection and documentation for engineering studies, contributing to evidence-based decisions and innovative solutions.

• Environmental Monitoring & Cleanroom Support
  • Perform routine environmental monitoring of cleanrooms (viable and non‑viable monitoring)
  • Execute cleanroom testing per approved procedures and schedules.
  • Document, review, and trend environmental monitoring results to identify opportunities for improvement and proactively address potential risks.
  • Support investigations and corrective actions related to environmental excursions through thorough analysis, ownership, and cross-functional teamwork.
  • Manage and process environmental testing samples in coordination with engineering.

• Compliance & Audit Support
  • Support internal, customer, and regulatory audits by providing calibration, testing, and environmental monitoring records.
  • Maintain compliance with FDA QSR (21 CFR 820), ISO 13485, and internal SOPs while promoting a culture of quality, accountability, and ethical decision-making.
  • Escalate quality and compliance risks to QA management as appropriate.

• Demonstrate punctuality, reliability, accountability, and a collaborative mindset while consistently delivering high-quality work and supporting team success.

WHAT YOU'LL BRING:

Education:

• High school or higher required.

Experience:

• Minimum 5 years of on‑the‑job experience supporting Endologix product manufacturing and quality functions.

Skills/Competencies:

• ASQ Certified Calibration Technician (CCT) certification or equivalent.
• Implantable medical device quality testing

• • Product lot release and acceptance activities
  • Review and processing of product work orders
  • Use and control measurement and test equipment

• Experience supporting regulated manufacturing environments (FDA QSR / ISO 13485).
• Strong diligence and documentation accuracy.
• Mechanical aptitude and working knowledge of measurement instruments.
• Proficiency in Microsoft Excel and Word.
• Ability to read and interpret technical procedures, drawing, specifications, ASTM standards, and medical device regulatory requirements.
• Strong written and verbal communication skills for reports, correspondence, and presentations.
• Problem-solving skills with the ability to work in a cross-functional environment and manage multiple priorities.
• Experienced in using measuring equipment such as Microscope, CMM, Instron tester, calipers, pin gauge, micrometer, snap gauge etc.
• Ability to work extended hours and flex shifts to deliver projects on time.

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:

• Pay rate of $34.02-$41.58/hour
• 5% 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, which operates as a Rhevera Medical company, 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.