Quality Engineering Technician - 2nd shift

Employment Type

: Full-Time

Industry

: Engineering



Job Description

An employer in San Diego, CA is looking for a Quality Engineering Technician II
  • 2nd shift. The incumbent will perform pipetting as part of cartridge final product acceptance, environmental testing as part of the clean room requirements, and internal tool calibrations. The Technician will support product qualification testing such as: bacterial endotoxin testing and send samples to suppliers to perform product bioburden/sterility (i.e. dose auditing). Expectations also include monitoring the cleanroom and temperature/humidity-controlled environments for breaches of specification limits and assist in investigations of breaches, maintaining laboratory / environmental monitoring and control equipment, and preparing and maintaining quality test reports/procedures in the electronic document management system. Operates equipment such as: micropipettes, repeating pipettes, air quality monitoring equipment, microplate readers. The Technician will also be responsible for inventorying, ordering, receiving, and stocking materials, supplies, and equipment for use in testing.
  • Minimum Requirements

  • Experience with pipettors, reagent handling, and laboratory best practices.
  • Previous experience re-calibrating related tools.
  • 2+ years of quality and/or manufacturing experience in an FDA regulated industry
  • Understanding of GMP regulations and Process Controls, including document review, in-process and final acceptance criteria, identification and traceability requirements, and segregation of materials.
  • Knowledge of concepts associated with microbiology.
  • Experience with QSRs, QC testing methods.
  • Experience with lot release, document review, and in-process inspection.
  • Desired Skills

  • Related experience within a medical device industry.
  • * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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