Quality Engineer

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.