Quality Engineer - Process Control, CAPA & Compliance

Medline; Chicago, Northern (IL, KY); Hybrid; USD 79,000 - 119,000; Full time

Job summary

Medline is seeking a Quality Engineer to independently set basic quality standards for in-process activities and lead testing, sampling, and training initiatives in a hybrid role based in Chicago, IL. You will evaluate production processes, design experiments, and apply SPC to drive improvements while maintaining CE, 510K, and other regulatory documentation.

You will collaborate with suppliers, manage CAPA/SCAR actions, and build robust product documentation (DMRs, design history, and risk

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
• Intermediate skill level in Microsoft Excel.
• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
• Position requires up to 15% travel.

Responsibilities

• Develop and implement methods and procedures for process control, validation, testing, and inspection.
• Design experiments to understand sources of variation and apply SPC to evaluate processes.
• Lead supplier qualifications and collaborate with suppliers on CAPA/SCAR.
• Prepare and maintain Design Control files, DMRs, and CE technical files.
• Coordinate product testing with internal and external laboratories as required.

Skills

MS Office

Time management

Problem solving

Education

Bachelor's degree in Engineering, Science, or Math

Tools

MS Excel

21 CFR 820

ISO 13485

Job description

Medline is seeking a Quality Engineer to independently set basic quality standards for in-process activities and lead testing, sampling, and training initiatives in a hybrid role based in Chicago, IL. You will evaluate production processes, design experiments, and apply SPC to drive improvements while maintaining CE, 510K, and other regulatory documentation.

You will collaborate with suppliers, manage CAPA/SCAR actions, and build robust product documentation (DMRs, design history, and risk