Biomedical Quality Technician

3 weeks ago


Irvine, United States Akkodis Full time

A Biomedical Quality Technician position in Irvine, CA is available courtesy of Akkodis.


  • Type: Contract
  • Duration: 3 months; possible extension
  • Location: Irvine, CA
  • Range: $27.11


Biomedical Quality Technician


RESPONSIBILITIES:

  • Responsible for inspection and testing of assigned medical device components in accordance to QSR, company policy and approved procedures.
  • Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and policies, procedures and guidelines, this position:
  • Responsible for communicating business related issues or opportunities to next management level.
  • Performs other duties assigned as needed.
  • Performs dimensional and visual inspection of assigned products per approved procedures / inspection plans.
  • Documents all inspection / test results and any non-conformances found during inspection, testing or evaluations according to the written procedure.
  • Performs disposition of material.
  • Maintain knowledge of all procedures, change to specifications and new regulations related to areas of responsibilities.
  • Review supplier inspection / test results; provide feedback to engineers and suppliers.
  • Support associates on defect awareness, inspection methods and specifications requirements.
  • Perform device History Records (DHR) / batch records review for product release.
  • Support in training of new QA Technician for proper use of inspection methods and procedures.


REQUIREMENTS:

  • Minimum of 1 years of related work experience in Biomedical, Pharmaceutical or similar environment.
  • 1 or more years of experience reviewing Batch Records or DHR' (or similar documents) a must.
  • Verbal and written communication skills.
  • Experience with ERP systems (Oracle preferred).
  • Proficiency in Salesforce a plust.
  • PC Literacy and use of Microsoft office.
  • Be able to read and interpret engineering drawings a plus.
  • Knowledge of ANSI-Z-1.4 and 1.9 lot sampling a plus.



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