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Quality Engineer (Sparks Glencoe)

Quality Engineer (Sparks Glencoe)

ALOIS SolutionsSparks Glencoe, MD, United States
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Client : Medical Device Manufacturing Domain

Position : Quality Engineer II (Calibration) (CFNJP00052409)

Duration : 3+ months Contract (possibility of Extension)

Location : Sparks, MD, 21152

Must-Have Skills : Calibration experience, Ability to use a computer for excel type data input, Blue Mountain experience

Interview Process : (e.g., in person, phone screen, virtual interview, panel, etc.) Phone screen then In Person

  • The Quality Engineer II (Calibration) is responsible for the implementation, performance and documentation of the IDS Baltimore calibration program, supporting multiple facility locations within Baltimore.
  • This includes process control and testing equipment at all locations.
  • Troubleshoots, repairs, provides required maintenance and assists in the purchase of applicable equipment.
  • May supervise exempt and non-exempt employee(s) and contractor calibrations.
  • Administers and maintains the calibration program for IDS locations within Baltimore assuring compliance to ISO and GMP regulations.
  • Documents calibration system via department Standard Operating Procedures and Quality Manual. Participates in external customer audits of the Diagnostics calibration program.
  • Establishes calibration schedule and ensures compliance of operation and calibration department to schedule. Plans and conducts calibration and certification testing at required intervals on the following equipment : temperature indicators, recorders and controllers, timers, centrifuges, tachometers, pressure and vacuum indicators and recorders, flowmeters, pH meters, %RH indicators and recorders, CO2 incubators and recorders, thermocouples, RTD's, thermometers, and other temperature probes and instruments as required.
  • Maintains open communication and excellent customer service to internal customers.
  • Maintains and assures required calibration renewals of reference standards and maintains history files.
  • Develops administers and maintains applicable calibration procedures and data sheets that meet regulatory requirements.
  • Supervises contractor calibrations to assure FDA, GMP and Corporate compliance.
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Quality Engineer • Sparks Glencoe, MD, United States

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