Quality Engineer - Process Control, CAPA & Regulatory

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Engineer in Chicago to independently set basic quality standards for in-process and development testing. You will lead methods development, vendor management, and the maintenance of DMRs, product specs, design control files, and CE/510K documentation.

The role requires at least 2 years in Quality or Engineering, with experience in Medical Devices or related fields preferred.

Qualifications

• Bachelor’s degree in a related technical field is required.
• Minimum 2 years of experience in Quality or Engineering.
• Experience in Medical Devices, Drugs, or related fields is preferred.

Responsibilities

• Set quality standards for in-process and development testing.
• Design experiments and apply SPC to analyze data and drive improvements.
• Lead CAPA, SCAR events and supplier quality initiatives.
• Prepare and maintain 510K submissions and related design files.
• Ensure compliance with 21 CFR 820, ISO 13485 and other regulations.

Skills

SPC (Statistical Process Control)

CAPA/SCAR

Vendor management

MS Office Suite

Advanced Excel

Regulatory knowledge (21 CFR 820, ISO

Time management

Problem solving

Quality assurance

Education

Bachelor’s degree in Engineering, Science, Math

Tools

Document control systems

Quality management systems

Job description

Medline Industries, LP is seeking a Quality Engineer in Chicago to independently set basic quality standards for in-process and development testing. You will lead methods development, vendor management, and the maintenance of DMRs, product specs, design control files, and CE/510K documentation.

The role requires at least 2 years in Quality or Engineering, with experience in Medical Devices or related fields preferred.