Quality Engineer

Job Title: Quality EngineerLocation: Northfield, ILExperience: 3+ YearsOnly : W2Job Description:We are seeking a Quality Engineer to support product quality and remediation efforts in a regulated environment. The role involves ensuring compliance, improving processes, and supporting product development across medical devices, OTC drugs, or related products.Key Responsibilities:Support design control, CAPA, risk management, and quality systemsLead investigations for non-conformance and implement corrective actionsManage supplier quality, audits, and vendor qualificationsEnsure compliance with FDA (21 CFR 820) and ISO 13485 standardsDevelop and maintain Device Master Records (DMR) and technical documentationPerform process validation, testing, and quality inspectionsApply statistical analysis (SPC) for process improvementCoordinate testing with internal and external labsRequired Skills:Experience in Quality Engineering / AssuranceKnowledge of CAPA, Design Controls, Risk ManagementFamiliarity with FDA regulations and ISO standardsStrong analytical and problem-solving skillsProficiency in MS Excel and data analysisPreferred Skills:Experience in Medical Devices / Pharma / OTC productsKnowledge of 510(k), CE documentationExposure to supplier quality managementRecruiter | S4 AnalyticsPlease feel free to reach me at + 1(469)-429-8065Pavan@s4analytix.com