Senior Quality Engineer — Process Improvement & Compliance

Medline; Chicago (IL); Hybrid; USD 101,000 - 152,000; Full time

Job summary

Medline Industries, LP in Chicago, IL seeks a Sr. Quality Engineer to independently set basic quality standards for in-process and finished products, lead testing, sampling and training programs, and drive process control improvements.

You will design experiments, apply SPC, collaborate with suppliers on CAPA/SCAR, maintain DMRs and CE files, and support FDA/ISO compliance while mentoring teammates.

Qualifications

• Bachelor’s degree is required in engineering, science, math or related field.
• 4+ years of experience in quality or engineering roles.
• Experience with government/industry QA codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).

Responsibilities

• Develop methods and procedures for process control, validation, testing, and inspection to ensure products are ideal and functional.
• Design complex experiments to understand sources of variation and apply SPC to analyze data.
• Lead CAPA and supplier quality improvement activities, including supplier qualifications.
• Create and maintain DMRs, product specifications, design control files, and CE technical files.
• Coordinate product testing with internal and external labs and support regulatory submissions as required.

Skills

SPC

Quality assurance

CAPA

Design of experiments

Vendor management

Problem solving

Education

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

Tools

MS Office Suite

Microsoft Excel (advanced)

Job description

Medline Industries, LP in Chicago, IL seeks a Sr. Quality Engineer to independently set basic quality standards for in-process and finished products, lead testing, sampling and training programs, and drive process control improvements.

You will design experiments, apply SPC, collaborate with suppliers on CAPA/SCAR, maintain DMRs and CE files, and support FDA/ISO compliance while mentoring teammates.