Quality Engineer - Medical Devices, SPC, CAPA & CE

Medline Industries, Inc.; 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 in Chicago, IL is seeking a Quality Engineer to set basic quality standards, lead testing methods, and manage documentation including DMRs and CE files.

You will design experiments, apply SPC, collaborate with suppliers on CAPA and SCAR, and ensure compliance with 21 CFR 820 and ISO13485, with up to 15% travel.

This role requires a Bachelor’s in Engineering/Science and at least 2 years in quality or engineering.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 2 years in Quality or Engineering.
• Familiar with SPC, testing and inspection methods.
• Knowledge of 21 CFR 820 and ISO13485 preferred.

Responsibilities

• Set and implement basic quality standards for in-process work.
• Design experiments; apply SPC to analyze data and guide decisions.
• Perform product testing and analyze results to reduce defects.
• Lead supplier qualifications and CAPA/SCAR activities.
• Develop device master records and CE/510(k) technical files.
• Coordinate testing with internal and external labs; ensure compliance.
• Lead investigations of non-conformances and preventive actions.

Skills

Self-motivation

Time management

Problem solving

MS Office

Excel skills

Quality systems

Travel readiness

Education

Bachelor's degree in Engineering/Science

Job description

Medline Industries, LP in Chicago, IL is seeking a Quality Engineer to set basic quality standards, lead testing methods, and manage documentation including DMRs and CE files.

You will design experiments, apply SPC, collaborate with suppliers on CAPA and SCAR, and ensure compliance with 21 CFR 820 and ISO13485, with up to 15% travel.

This role requires a Bachelor’s in Engineering/Science and at least 2 years in quality or engineering.