Quality Engineer — Anesthesia Devices, Impactful QA

Medline Industries, LP; 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 to independently set quality standards for in‑process and development testing, while leading efforts to develop methods for testing, sampling and training. You will evaluate production processes, qualify vendors, generate Design Master Records and CE technical files, and drive CAPA actions.

The role requires a bachelor's degree in a technical field and 2+ years in Quality or Engineering, with experience in process control, validation, and

Qualifications

• Bachelor's degree in engineering, science, math or related technical field.
• 2+ years of experience in Quality or Engineering.
• Experience with design controls, CAPA/SCAR and CE/510(k documentation is preferred.

Responsibilities

• Set and maintain basic quality standards for in-process and development testing.
• Design experiments to understand sources of variation in products and processes.
• Apply SPC to analyze data and guide process improvements.
• Perform product testing and analysis to maintain quality and minimize defects.
• Generate reports and investigate defective products to identify trends and drive corrective actions.
• Collaborate with suppliers to resolve quality issues and support supplier qualification programs.
• Lead design documentation reviews for compliance with requirements and standards.
• Coordinate product testing with internal/external labs and support CE/510(k) submissions.

Skills

SPC experience

Quality systems

MS Office proficiency

Analytical thinking

Education

Bachelor’s degree in Engineering/Science/Math or related field

Job description

Medline Industries, LP is seeking a Quality Engineer to independently set quality standards for in‑process and development testing, while leading efforts to develop methods for testing, sampling and training. You will evaluate production processes, qualify vendors, generate Design Master Records and CE technical files, and drive CAPA actions.

The role requires a bachelor's degree in a technical field and 2+ years in Quality or Engineering, with experience in process control, validation, and