Job Information
Logging-In.com LLC Quality Engineer (Has multiple openings) in Farmington, Michigan
Develop and execute software tests to identify software problems and their causes. Test system modifications to prepare for implementation. Develop and deliver detailed DI metrics to site leadership monthly using TrackWise, Power BI, and other management systems to track compliance performance. Perform comprehensive DI risk assessments including preliminary assessments, system admin audit trails, electronic data reviews, and validation protocol evaluations. Performed impact assessments and validated systems to meet 21 CFR Part 11 and Annex 11 requirements. Performed Gage R&R studies and created control plans supporting quality assurance objectives.