Quality Engineer: Process Control & CAPA Expert

Medline Industries; 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 in Illinois seeks a Quality Engineer to set basic in-process quality standards and lead method development for testing and sampling. You will design experiments, apply SPC, and drive corrective actions with suppliers to maintain product quality.

You will build and maintain Device Master Records, support 510K submissions, and ensure compliance with 21 CFR 820 and ISO 13485 across global operations. Travel up to 15% may be 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 quality codes and standards (e.g. 21 CFR 820, ISO 13485).
• Experience leading CAPA investigations and process improvements.

Responsibilities

• Develop and implement methods for process control, validation, testing, and inspection to ensure product quality.
• Design experiments to understand sources of variation and guide process improvements.
• Lead supplier qualifications and corrective actions (CAPA/SCAR).
• Prepare and maintain Device Master Records and CE/510K documentation as required.
• Coordinate product testing with internal and external labs; ensure regulatory compliance.

Skills

SPC analysis

CAPA

SCAR

Vendor management

Quality systems

Problem solving

MS Excel

Documentation

Education

Bachelor's degree in Engineering or related technical field

Tools

MS Office Suite

Job description

Medline Industries in Illinois seeks a Quality Engineer to set basic in-process quality standards and lead method development for testing and sampling. You will design experiments, apply SPC, and drive corrective actions with suppliers to maintain product quality.

You will build and maintain Device Master Records, support 510K submissions, and ensure compliance with 21 CFR 820 and ISO 13485 across global operations. Travel up to 15% may be required.