QA Technician - Medical Devices, Calibration & Testing

Rhevera Medical

Santa Rosa (CA)

On-site

USD 97,482,000 - 119,143,000

Full time

8 days ago

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Benefits offered by this job

Health insurance
Dental insurance
Vision insurance
Flexible HSAs/FSAs
401(k) with company match
Paid time off
Hybrid or remote work options
Employee wellness resources
Employee recognition programs
Commuter benefits

Job summary

Endologix LLC is seeking a Quality Assurance Technician to support implantable medical device quality activities. You will perform calibration, environmental monitoring, and product testing to ensure FDA QSR and ISO 13485 compliance.

The role emphasizes documentation accuracy, cross‑functional collaboration, and adherence to quality systems to safeguard patient safety and product quality.

Qualifications

  • ASQ CCT certification or equivalent.
  • Experience in regulated manufacturing environments (FDA QSR/ISO 13485).
  • Strong documentation accuracy and data integrity.
  • Ability to read procedures, drawings and specifications.

Responsibilities

  • Calibrate and manage measurement systems with QA oversight.
  • Perform product acceptance and lot release testing.
  • Support engineering with testing, verification, and validation.
  • Conduct environmental monitoring of cleanrooms and manage samples.
  • Support internal and regulatory audits with records and documentation.

Skills

ASQ CCT
Calibration
Quality testing
Lot release
Documentation
FDA QSR
ISO 13485
Excel & Word

Education

High school or higher

Tools

Microscope
CMM
Instron
Calipers
Micrometer
Snap gauge

Job description

Endologix LLC is seeking a Quality Assurance Technician to support implantable medical device quality activities. You will perform calibration, environmental monitoring, and product testing to ensure FDA QSR and ISO 13485 compliance.

The role emphasizes documentation accuracy, cross‑functional collaboration, and adherence to quality systems to safeguard patient safety and product quality.

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