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. Works with engineers in conducting experiments.
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 will:
Develop written calibration procedures:
Schedule calibration activities (internal and external):
Perform equipment calibration and repair:
Ensure proper documentation of calibrations results:
Maintain the equipment calibration database.
Must be proficient with mechanical equipment calibration methodologies, 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 satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.Key Responsibilities Include:
Calibrate equipment such as scales/balances, thermometers, temperature & humidity chambers, dimensional equipment, mass, force, dewpoint, pressure/vacuum, time, velocity, ovens, refrigerators/freezers, differential pressure, etc.
Generate reports, records, update histories, and perform data entry in the calibration database.
Review documentation for accuracy and compliance.
Install, troubleshoot, adjust, and repair measuring equipment.
Maintain calibration test equipment, work area, and laboratory.
Work with relevant industry guidelines: ISO-, ANSI-Z or ISO-.
Use the Microsoft Suite of products: Word, Excel, Outlook.
Utilize calibration software.
Follow related procedures, cGMPs, and industry practices.
Work in a cleanroom and controlled environment.
Utilize knowledge of ESD.
Use sophisticated programs to collect and evaluate data to assist in assessing and documenting results of quality assurance and control processes.
Determine and may assist in developing methods and procedures for quality assurance and control.
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 an EPA controlled environment.
Experience and Education Requirements:Diploma or equivalent. Typically requires a minimum of 4-6 years of industry experience or equivalent.
Preferred:At least 3 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.#J-18808-Ljbffr