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Quality Engineer

Company Name: Inari Medical
Location: Irvine
Job Type: Full-time Regular
Contact Name: Eben Gordon
Phone:  949-600-8433 x114
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Job Description 

  • Support implementation of FDA GMP and ISO 13485 compliant quality system. Assist in the implementation of ISO 13485:2016
  • Oversee QA/QC activities, including receiving and finished product inspection, device history record/product release, environmental control, calibration, corrective action, supplier approval, and product complaint file maintenance.
  • Execute Document Control activities.
  • Initiate document changes and create QA/QC procedures, protocols, system documents and test reports as required.
  • Review document changes and design history for impact on specifications, product quality and compliance.
  • Provide QA/QC direction to QC inspector, as required.

Job Requirements 

  • A Bachelors degree, preferably in the areas of engineering or science.
  • Experience in the Quality System of a medical device manufacturer.
  • Knowledge of 21 CFR Part 820 and ISO 13485