Summary:

Performs functions associated with quality control and quality assurance operations, including working with engineers in set-up and calibration tasks and quality assurance procedures related to production or operations. Uses programs to collect and evaluate data to assist in assessing and documenting results of quality assurance and control processes. Determines and may assist in developing methods and procedures for quality assurance and control.

*Must be able to work in designated shift pattern and flexible hours; including possible rotating schedules that may include early morning or evening hours, holidays and weekends. Overtime may be required and may be mandatory at times.

 

Essential Duties and Responsibilities:

Incumbent is responsible for performing a variety of work functions related to equipment calibration and maintenance of the equipment calibration system. Incumbent provides support as responsibilities appointed by Supervisor/ Manager. Incumbent will perform equipment calibration and repair, ensure proper documentation of calibrations results, and maintain the equipment calibration database. Responsible for troubleshooting and repair. Support process and equipment validations and assist with out-of-tolerance equipment investigations, as necessary. 

 

To perform this job successfully, an individual must be able to execute each essential duty satisfactory.  The requirements listed below are representative of the knowledge, skill and/or ability required. 

•    Calibrate equipment for example; scales/balances, thermometers, temperature & humidity chambers, dimensional equipment, mass, force, dewpoint, pressure/vacuum, time, velocity, ovens, refrigerators/freezers, differential pressure, etc.
•    Review documentation for accuracy and compliance
•    Generate reports, records, update histories, and perform data entry in the calibration database
•    Install, troubleshoot, adjust, and repair measuring equipment
•    Utilize calibration software  
•    Follow related SOPs, cGMPs, and industry practices
•    Work in a cleanroom environment
•    Work with cross-functional department personnel, as necessary, to support quality and business objectives

 

Required Qualifications:

Experience calibrating equipment, for example; scales/balances, thermometers, temperature & humidity chambers, dimensional equipment, mass, force, dewpoint, pressure/vacuum, time, velocity, ovens, refrigerators/freezers, differential pressure, etc. Experience reviewing documentation for accuracy and compliance

 

Preferred Qualifications:

Experience generating reports, adding records, updating histories, and performing data entry in the calibration database

Experience installing, troubleshooting, adjusting, and repairing measuring equipment Experience maintaining calibration test equipment, work area, and lab Experience with medical device manufacturing Calibration software experience Previous work experience in an FDA or regulated industry Experience working with GMP practices Calibration Technician Certification (CCT) and/or industry Technical Certification is preferred. Calibration database management and navigation experience, Blue Mountain (RAM) Software is preferred. Knowledge of ESD, with experience working in controlled environment.

 

Experience and Education Requirements:

Typically requires a minimum of 2-4 years of related experience and High School diploma/certificate or equivalent.

 

Preferred: At least 1 years related calibration experience of the following metrology disciplines: rf electronics, electrical, pressure, mass, ESD, dimensional or temperature or equivalent combination of education and experience.