ALOIS Solutions
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.
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.