Quality Engineer, Medical Devices — Process Control & CAPA

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP in Chicago, IL seeks a Quality Engineer/Engineer who will independently set basic quality standards for in-process activities and lead efforts to test, sample, and train. You will evaluate production processes and drive improvements while managing vendor relationships and documentation.

Responsibilities include designing experiments, applying SPC, and leading corrective actions to reduce defects. Travel up to 15% may be required.

Qualifications

• Experience using statistical methods to improve processes.
• Knowledge of quality systems and regulatory requirements.
• Ability to design experiments and analyze data.

Responsibilities

• Develop methods for process control, validation, and inspection.
• Lead supplier qualifications and CAPA.
• Prepare and review device master records and 510K-related documents.

Skills

SPC methods

Quality assurance codes (21 CFR 820, I

MS Office Suite

Microsoft Excel (advanced)

Problem solving

Education

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

Tools

MS Office

Microsoft Excel

Job description

Medline Industries, LP in Chicago, IL seeks a Quality Engineer/Engineer who will independently set basic quality standards for in-process activities and lead efforts to test, sample, and train. You will evaluate production processes and drive improvements while managing vendor relationships and documentation.

Responsibilities include designing experiments, applying SPC, and leading corrective actions to reduce defects. Travel up to 15% may be required.