Quality Assurance Technician

careersus-endologix; Santa Rosa (CA); On-site; USD 47,000 - 58,000; Full time

Benefits offered by this job

Flexible work arrangements

401(k) match

Health, dental, vision insurance

Paid time off

Job summary

Endologix LLC in California is seeking a Quality Assurance Technician to support implantable medical device quality, manufacturing, and R&D activities through rigorous product quality control testing and calibration program administration. You will help ensure FDA QSR and ISO 13485 compliance and maintain measurement systems.

This role requires hands-on calibration, environmental monitoring, and test support with a focus on data integrity, traceability, and cross‑functional collaboration to

Qualifications

• ASQ CCT certification or equivalent required.
• Experience with implantable medical device QA and testing.
• Familiarity with FDA QSR and ISO 13485 requirements.
• Calibrations, measurement equipment control, and documentation.
• Ability to read procedures, drawings, and specs.

Responsibilities

• Administer calibration program under QA oversight and maintain equipment traceability.
• Perform product acceptance testing and lot release per procedures.
• Support engineering testing and verification activities.
• Environmental monitoring of cleanrooms and data trending.
• Assist with investigations and CAPAs related to quality events.

Skills

ASQ CCT

Implantable device QA

Measurement equipment

Excel & Word

FDA QSR ISO13485

Technical procedures

Written communication

Problem solving

Calibration & testing

CMM

Shift flexibility

Environmental monitoring

Education

High school or higher

Tools

Microscope

CMM

Instron tester

Calipers

Pin gauge

Micrometer

Snap gauge

Job description

Overview

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

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.

Responsibilities

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.

Qualifications

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 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.