Quality Engineer - Medical Devices (CAPA & Process)

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 in Chicago seeks a quality engineer to independently set basic quality standards for in-process and lead methods for testing, sampling and training. You will evaluate production processes, qualify and conduct vendor management, and maintain DMRs and CE technical files.

Responsibilities include SPC, CAPA, supplier qualifications, design control, and coordinating 510K submissions; travel up to 15% may be required.

Qualifications

• Bachelor's degree in a technical field is required.
• At least 2 years of experience in Quality or Engineering.
• Knowledge of SPC, CAPA and regulatory standards is preferred.

Responsibilities

• Develop methods and procedures for process control and validation.
• Design experiments to identify sources of variation.
• Apply SPC to analyze data and guide decisions.
• Lead supplier quality activities and CAPA investigations.
• Prepare product documentation and support CE/510(k) filings.
• Coordinate testing with internal and external labs; ensure compliance.

Skills

Process control

SPC (statistical process control)

CAPA

Vendor management

Data analysis

Design of experiments

MS Excel

Regulatory knowledge

Education

Bachelor's degree in Engineering/Science

Tools

MS Excel

Job description

Medline Industries, LP in Chicago seeks a quality engineer to independently set basic quality standards for in-process and lead methods for testing, sampling and training. You will evaluate production processes, qualify and conduct vendor management, and maintain DMRs and CE technical files.

Responsibilities include SPC, CAPA, supplier qualifications, design control, and coordinating 510K submissions; travel up to 15% may be required.