Quality Assurance Technician

Endologix • Santa Rosa, CA

1d • $34 - $42 • Hybrid

About The Position

Join our mission-driven Quality team as the Quality Assurance Technician at Endologix! 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. 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.

Requirements

• High school or higher required.
• Minimum 5 years of on‑the‑job experience supporting Endologix product manufacturing and quality functions.
• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• Competitive pay
• Solid benefits
• Career growth
• Culture that genuinely cares
• Flexibility
• Purpose
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED