Quality Engineer

Job Title:Quality Engineer Location:Northfield, IL Experience:3+ Years Only : 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: Supportdesign control, CAPA, risk management, and quality systems Leadinvestigations for non-conformance and implement corrective actions Managesupplier quality, audits, and vendor qualifications Ensure compliance withFDA (21 CFR 820) and ISO 13485 standards Develop and maintainDevice Master Records (DMR) and technical documentation Performprocess validation, testing, and quality inspections Applystatistical analysis (SPC) for process improvement Coordinate testing with internal and external labs Required Skills: Experience inQuality Engineering / Assurance Knowledge ofCAPA, Design Controls, Risk Management Familiarity withFDA regulations and ISO standards Strong analytical and problem-solving skills Proficiency inMS Excel and data analysis Preferred Skills: Experience inMedical Devices / Pharma / OTC products Knowledge of510(k), CE documentation Exposure tosupplier quality managementRecruiter | S4 Analytics Please feel free to reach me at + 1(469)-429-8065 Pavan@s4analytix.com