Summary:Performs functions associated with quality control and quality assurance operations, including working with other technicians to perform calibration as per approved procedures; review calibration certificates for compliance; review and processing of requests in the equipment control database (e.g.
Regulatory Asset Manager (RAM)); shipping and Receiving equipment to/from vendor; assist other areas of QA, as needed and additional tasks, as needed*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 Leader/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.Performs functions associated with quality control and quality assurance operations, including working with engineers in set-up and calibration tasks and carrying out quality assurance procedures related to production or operations.Calibrate equipment for example, scales/balances, thermometers, temperature & humidity chambers, dimensional equipment, mass, force, dewpoint, pressure/vacuum, time, velocity, ovens, refrigerators/freezers, differential pressure, etcReview documentation for accuracy and complianceGenerate reports, records, update histories, and perform data entry in the calibration databaseInstall, troubleshoot, adjust, and repair measuring equipmentUtilize calibration softwareFollow related SOPs, cGMPs, and industry practicesWork in a cleanroom environmentWork with cross-functional department personnel, as necessary, to support quality and business objectivesUses sophisticated programs to collect and evaluate data to assist in assessing and documenting results of quality assurance and control processesDetermines and may assist in developing methods and procedures for quality assurance and controlRequired Qualifications:Diploma or equivalentExperience reviewing documentation for accuracy and compliance.Preferred 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, etcExperience generating reports, adding records, updating histories, and performing data entry in the calibration databaseExperience installing, troubleshooting, adjusting, and repairing measuring equipmentExperience maintaining calibration test equipment, work area, and labExperience with medical device manufacturingCalibration software experiencePrevious work experience in an FDA or regulated industryExperience working with GMP practicesExperience and Education Requirements:Diploma or equivalentPreferred: At least 1 year related calibration experience of the following metrology disciplines: rf electronics, electrical, pressure, mass, ESD, dimensional or temperature or equivalent combination of education and experience