Quality Engineer, Medical Devices: Process Control & CAPA

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

Job summary

Medline in Chicago is seeking a Quality Engineer for Remedy & Readycare on a hybrid schedule. You will set basic quality standards for in‑process work and lead testing, sampling and training programs to ensure products are safe, effective, and compliant.

The role involves process evaluation, data analysis, and collaboration with suppliers on CAPA and supplier quality actions. The ideal candidate has a bachelor’s degree in engineering/science/math and at least two years of quality or engineering

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Working knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Manage development and implementation of methods for process control, validation, improvement, testing and inspection.
• Design experiments to understand sources of variation and apply SPC.
• Lead investigations of non-conformances and drive CAPA/SCAR actions and supplier quality improvements.
• Build and maintain product documentation (Device Master Records) and support 510(k) submissions and regulatory letters.

Skills

SPC methods

CAPA

Supplier quality

Design control

Problem solving

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office Suite

Excel

Job description

Medline in Chicago is seeking a Quality Engineer for Remedy & Readycare on a hybrid schedule. You will set basic quality standards for in‑process work and lead testing, sampling and training programs to ensure products are safe, effective, and compliant.

The role involves process evaluation, data analysis, and collaboration with suppliers on CAPA and supplier quality actions. The ideal candidate has a bachelor’s degree in engineering/science/math and at least two years of quality or engineering