Quality Engineer

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