Quality Engineer: Medical Devices, CAPA & CE Files

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

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries in Chicago, IL seeks a quality-focused engineer to set basic in-process quality standards and lead methods for testing, sampling, and training. You will manage vendor relations, generate DMRs and product specs, and support CE technical files and 510K submissions as needed.

The role requires designing experiments, applying SPC, and driving corrective actions with suppliers. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or other related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience applying SPC methods for process analysis.
• Familiarity with 21 CFR 820 and ISO13485 quality standards.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments to understand sources of variation and guide decisions.
• Collaborate with suppliers on CAPA and supplier quality improvements.
• Create/maintain design controls, DMRs, and CE technical files as required.
• Coordinate product testing with internal/external labs and ensure regulatory compliance.
• Lead investigations of non-conformances and drive CAPA actions.

Skills

Self-motivation & independence

Time management

Problem solving

Regulatory knowledge (21 CFR 820, ISO

Education

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

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries in Chicago, IL seeks a quality-focused engineer to set basic in-process quality standards and lead methods for testing, sampling, and training. You will manage vendor relations, generate DMRs and product specs, and support CE technical files and 510K submissions as needed.

The role requires designing experiments, applying SPC, and driving corrective actions with suppliers. Travel up to 15% may be required.