Quality Engineer II

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

• 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 Client Diagnostics calibration program.
• Establishes calibration schedule and ensures compliance of operation and calibration department to schedule.
• 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.

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.

Must-Have Skills: 

• Calibration experience.
• Ability to use a computer for excel type data input
• Nice-to-Have Skills (if any):
• Blue Mountain experience (a software used in the Life Sciences industry for managing calibration and maintenance of assets within a GMP-compliant framework.)

Interview Process: 

• Phone screen then In Person.