Quality Engineer – Medical Devices, CAPA & CE

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

Job summary

Medline Industries, Inc. is seeking a quality professional to set basic quality standards and lead testing, sampling and training initiatives across in-process activities. You will design experiments, apply SPC, and coordinate with suppliers to maintain quality and compliance.

The role involves developing documentation such as DMRs and CE technical files, performing design reviews, and leading CAPA activities. Travel up to 15% may be required.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field required.
• At least 2 years of experience in Quality or Engineering.

Responsibilities

• Set basic quality standards for in-process and guide testing, sampling and training efforts.
• Design experiments and apply SPC to analyze variation and drive improvements.
• Lead CAPA, SCAR, supplier quality initiatives and supplier qualifications.
• Develop and maintain product documentation (e.g., Device Master Records) and CE technical files.
• Coordinate product testing with internal and external labs and ensure regulatory compliance.
• Perform quality reviews of design documentation and investigate non-conformances to drive corrective actions.

Skills

MS Office

Advanced Excel

CAPA

Regulatory knowledge

Education

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

Job description

Medline Industries, Inc. is seeking a quality professional to set basic quality standards and lead testing, sampling and training initiatives across in-process activities. You will design experiments, apply SPC, and coordinate with suppliers to maintain quality and compliance.

The role involves developing documentation such as DMRs and CE technical files, performing design reviews, and leading CAPA activities. Travel up to 15% may be required.