Calibration Control Specialist (Quality)

ARCH•Blandon, PA

About The Position

The Calibration Control Technician will schedule and perform internal and external calibrations, perform gauge repairs and adjustments, and meticulously document results of calibrations. Essential Duties and Responsibilities include the following. Other duties may be assigned. Compare instrument readings against established standards, making adjustments for accuracy Maintain gauge standards and certificates of calibration in accordance with AS9100, ISO13485, and FDA 21 CFR 820 requirements Maintain active and inactive gauges within the calibration database Check equipment for defects, perform preventative maintenance, and execute repairs or upgrades Identify gauges that need to be calibrated or removed from service Conduct and record gauge calibrations using NIST traceable master gauges Document gauge incidents meticulously and complete nonconforming gauge reports when gauges are found to be out of tolerance Perform gauge R&R according to ISO13485:2016 & FDA 21 CFR 820 (GMP) Arrange and schedule for outside service vendors to calibrate gauges not calibrated in-house, being point of contact Work alongside Quality Management to identify areas for improvement in the Calibration Control System Work alongside Quality Management in developing unique measurements and calibration protocols Ensure proper gauge labeling and traceability

Requirements

Equivalent to high school education or related experience or training; or equivalent combination of education and experience.
(3) years’ experience as a Calibration Specialist/Technician or similar position
Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality
Proficient with Microsoft Office
Proficient with Calibration Software; Calibration Recall Software & Unipoint eQMS.
Clear and thorough communication
Excellent organization skills

Nice To Haves

Certified Calibration Technician (preferred)

Responsibilities

Compare instrument readings against established standards, making adjustments for accuracy
Maintain gauge standards and certificates of calibration in accordance with AS9100, ISO13485, and FDA 21 CFR 820 requirements
Maintain active and inactive gauges within the calibration database
Check equipment for defects, perform preventative maintenance, and execute repairs or upgrades
Identify gauges that need to be calibrated or removed from service
Conduct and record gauge calibrations using NIST traceable master gauges
Document gauge incidents meticulously and complete nonconforming gauge reports when gauges are found to be out of tolerance
Perform gauge R&R according to ISO13485:2016 & FDA 21 CFR 820 (GMP)
Arrange and schedule for outside service vendors to calibrate gauges not calibrated in-house, being point of contact
Work alongside Quality Management to identify areas for improvement in the Calibration Control System
Work alongside Quality Management in developing unique measurements and calibration protocols
Ensure proper gauge labeling and traceability