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QA Associate

San Jose, CA
To inspect, audit and/or release medical device assemblies and support other QA functions, including (but not limited to) equipment calibration and documentation control activities. 
  • Inspect product assemblies such as phones and tablets according to documented procedures
  • Documenting inspection results on Lot History Records
  • Reviews and approves lot history records
  • Inspecting/verifying finished goods prior to shipment
  • Release of finished goods for shipment according to documented procedures
  • Performing incoming inspection of purchased materials according to specifications and document results
  • Performing QAD Application transactions to release materials from Quarantine to Raw Materials / Finish Goods locations.
  • Ensure that any non-conformances or deviations are properly approved and documented in the lot history records and incoming inspection records
  • Maintain quality records through filing or scanning processes
  • Ensuring proper operation of documents and records tracking
  • Assist with Document Control processes, and maintenance of quality records (electronic and hardcopy files).
  • Assist with Document Change Order preparation and completion
  • Assist with the identification of equipment due for calibration and collaborating with other functions to have the equipment properly calibrated and returned to its location of use
  • AA degree or equivalent experience
  • 2 years minimum experience in a medical device environment
  • Electronic document management system experience preferred
Knowledge and Training May Require:
  • Working knowledge of regulations, standards and guidelines related to quality
  • Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel
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