Abbott Diagnostics Scarborough Inc. – $49,878.00/Year

Bachelors or foreign equivalent degree in Engineering, Biotechnology, Chemistry, Life Sciences or in a closely related technical field of study with at least 2 years of professional quality engineering experience in i reviewing DHR for accuracy and completeness and provide guidance on FDA compliance and completion; ii facilitating or performing Nonconformance Reporting NCR and Corrective ActionsPreventative Action CAPA activities by completing risk assessments, root cause investigations, and action plans; iii performing Risk Management activities using Failure Mode Effect Analyses FMEAs, methodologies, including Design FMEA dFMEA and process FMEA pFMEA; iv Verification and Validation VV activities, including reviewing, authoring and approving Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, Process Performance Qualification PPQ, technical justifications, test protocols, and reports; v ensuring compliance with U.S. Food and Drug Administration FDA regulations and other regulatory requirements, particularly FDA 21 CFR 820, ISO 13485, and ISO 14971; vi conducting analyses using statistical techniques, including Gage Repeatability Reproducibility Gage RR, Tolerance intervals, and Process Capability assessments; and vii initiating Change Orders and authoring documentation for Process and Equipment Validation.