The Quality Auditor performs quality audits and related manufacturing activities to help ensure products meet quality, safety, and documentation requirements. The role may include preparing units; carrying out and validating unit start-up and shut-down procedures; reviewing wiring and electrical performance; visually inspecting units; and calibrating units. The auditor follows work instructions, records measurements, completes device history records in accordance with FDA GMP requirements, and documents nonconformances according to established procedures and GMP requirements. The position also involves troubleshooting equipment failures, performing assembly activities, and demonstrating work to train new employees. The role is onsite five days per week, Monday through Thursday from 4:30 p.m. to 3:00 a.m., with overtime on Fridays. Regular, reliable attendance and punctuality, including working scheduled overtime, are necessary. The employee is expected to follow workplace safety procedures, contribute to continuous improvement and team initiatives, and maintain productive working relationships and quality standards.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED