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Documentation Specialist

2 months ago

St Paul, United States The Fountain Group Full time

Pay: $25/HR – $27/HR


Qualifications:

  • High school diploma or equivalent qualification.
  • 1+ years’ experience working in manufacturing, or related field.
  • Excellent knowledge of MS Office and Excel.
  • Working knowledge of quality control standards, and when necessary testing techniques as well.
  • Working knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator
  • requirements.


Job Description:

  • Support document control, such as taking ownership of change order/change activity for coworker
  • Maintain Device History Record (DHR)/Lot History Record (LHR) log – creation of new lot numbers upon request and subsequent updates as appropriate
  • Assist in and/or perform final review of manufacturing DHR/LHR at close of or during manufacturing process and product release
  • Compile and archive completed and approved DHR/LHR
  • Compile and archive completed and approved incoming inspection records
  • Support incoming inspection as needed – understand and utilize the capability of measuring tools/fixtures; understand material specifications/inspection requirement of the components and parts; properly document inspection outcome
  • Support equipment controls and calibration/PM activities such as coordination with calibration/PM subject matter expert, handling the physical logistics and update of equipment log
  • Compile and archive various quality records in accordance with internal procedures and external standards/regulations
  • Communicate with coworkers and management if a nonconformance incident occurs
  • Support cross-functional areas as needed.