Quality Engineer

Job Description: You will perform critical functions in writing protocols, assisting in qualifying our Denville laboratory, calibrate and perform preventive maintenance on our testing equipment. You will also monitor qualifying events at our laboratory and manufacturing partner, including reviewing batch releases. Responsibilities: Demonstrates working understanding of medical design controls and regulatory requirements. Develops procedures and performs incoming, in-process, final inspection, and release activities. Interprets engineering drawings and determines methods for gauging (first article dimensions and incoming inspection dimensions); performs first article inspection and other inspection requirements. Initiates release of material to manufacturing. Maintain calibration system and calibrates equipment. Maintain preventative maintenance on equipment, fixtures, and gauges. Maintain GMP files. Maintain training files. Gather quality information for reports and create reports. Support Management Reviews. Support internal audits. Support other quality system requirements. Enters data into the computer for analysis. Runs lab testing, as required. Perform other related duties, as assigned. Requirements: Minimum of years hands-on inspection experience, preferable in a medical device area or equivalent. Experienced in quality systems (ISO and/or FDA's QSR). Experience with system documentation. Demonstrate proficiency in Excel or other spreadsheets, Word. Basic understanding of statistics. Specialized statistical software knowledge preferred. Demonstrated precise and thorough skill in mathematics. CMI, CQT (ratings), preferred. Experience in Quality. High School degree or above. Good Math skills are a must. Must be able to perform light lifting of up to pounds. Stand for hours. % periodic traveling (e g supplier audits, projects support as needed).

Created: 2025-11-20