Quality Engineer

Quality Engineer at S4 Analytics LLC Quality Engineer at S4 Analytics LLC in Winnetka, Illinois Posted in 26 minutes ago.

Type:

full-time

Job Description:

Job Title:

Quality Engineer Location:

Northfield, IL Experience:

3+

Years Only :

W2

Job 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 systems Lead investigations for non-conformance and implement corrective actions Manage supplier quality, audits, and vendor qualifications Ensure compliance with FDA (21 CFR 820) and

ISO 13485

standards Develop and maintain Device Master Records (DMR) and technical documentation Perform process validation, testing, and quality inspections Apply statistical analysis (SPC) for process improvement Coordinate testing with internal and external labs

Required Skills:

Experience in Quality Engineering / Assurance Knowledge of CAPA, Design Controls, Risk Management Familiarity with FDA regulations and ISO standards Strong analytical and problem-solving skills Proficiency in MS Excel and data analysis

Preferred Skills:

Experience in Medical Devices / Pharma / OTC products Knowledge of 510(k), CE documentation Exposure to supplier quality management Recruiter | S4 Analytics Please feel free to reach me at + 1(469)-429-8065 Pavan@s4analytix.com