QA Technician — Medical Devices (Hybrid/Remote)

Endologix

Santa Rosa (CA)

On-site

USD 47,000 - 57,000

Full time

9 days ago

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Benefits offered by this job

Discretionary bonus
Equity participation
Health, dental, vision
401(k) with match
Flexible work arrangements

Job summary

Endologix is seeking a Quality Assurance Technician to support implantable medical device QA, manufacturing, and R&D. You’ll administer calibration programs, ensure measurement system reliability, and perform environmental monitoring of cleanrooms to uphold FDA QSR and ISO 13485 standards.

The role emphasizes accurate documentation, test result traceability, and collaboration with engineering to drive product quality and patient safety.

Qualifications

  • ASQ Certified Calibration Technician (CCT) certification or equivalent.
  • Implantable medical device quality testing experience.
  • Product lot release and acceptance activities experience.
  • Experience supporting regulated manufacturing environments (FDA QSR / ISO 13485).
  • Strong documentation accuracy and ability to read technical procedures, drawings, and standards.

Responsibilities

  • Calibrate & manage measurement systems under QA oversight.
  • Maintain inventory and coordinate with external calibration providers.
  • Review calibration certificates for traceability and compliance.
  • Perform product acceptance and lot release testing per procedures.
  • Support environmental monitoring and cleanroom testing schedules.
  • Assist with data collection and reporting for engineering studies.

Skills

ASQ Certified Calibration Technician (
Implantable medical device quality
Product lot release and acceptance
Regulated manufacturing environments
Excel & documentation

Education

High school or higher

Tools

Microscope
CMM
Instron tester
Calipers
Pin gauge
Micrometer
Snap gauge

Job description

Endologix is seeking a Quality Assurance Technician to support implantable medical device QA, manufacturing, and R&D. You’ll administer calibration programs, ensure measurement system reliability, and perform environmental monitoring of cleanrooms to uphold FDA QSR and ISO 13485 standards.

The role emphasizes accurate documentation, test result traceability, and collaboration with engineering to drive product quality and patient safety.

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