Hybrid Quality Engineer – Medical Devices, Process & CAPA

Medline; Chicago (IL); Hybrid; USD 79,000 - 119,000; Full time

Job summary

Medline Industries, LP, Chicago, IL, is hiring a Quality Engineer for Capital Equipment & Furnishings. Under broad supervision, you will establish basic quality standards for in-process work and lead testing, sampling, and training to ensure products are safe and functional.

You will design experiments, apply SPC, analyze data, and coordinate with suppliers on CAPA, SCAR, and supplier qualifications. The role includes CE documentation, design controls, and potential 510K submissions as required;

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience with SPC and statistical data analysis.
• Familiarity with 21 CFR 820 and ISO 13485.

Responsibilities

• Develop and implement methods for process control, validation, and inspection.
• Design experiments to understand variation in products and processes.
• Apply SPC to analyze data and guide process improvements.
• Lead supplier quality activities, CAPA/SCAR, and supplier qualifications.
• Maintain product documentation and support CE/510K activities as required.

Skills

SPC

Problem solving

Time management

MS Office

Education

Bachelor’s degree in Engineering, Science, Math or related technical field

Tools

Excel

Job description

Medline Industries, LP, Chicago, IL, is hiring a Quality Engineer for Capital Equipment & Furnishings. Under broad supervision, you will establish basic quality standards for in-process work and lead testing, sampling, and training to ensure products are safe and functional.

You will design experiments, apply SPC, analyze data, and coordinate with suppliers on CAPA, SCAR, and supplier qualifications. The role includes CE documentation, design controls, and potential 510K submissions as required;