Quality Engineer - Medical Devices | CAPA, CE, 510(k)

Medline; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Chicago seeks a quality engineer to set basic in-process quality standards and lead development of testing, sampling, and training methods. You will evaluate production processes, recommend improvements, and manage design control files and CE technical documents.

You will collaborate with suppliers, perform CAPAs, support 510(k) submissions, and ensure compliance with 21 CFR 820 and ISO 13485.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• Minimum 2 years of experience in Quality or Engineering.
• Up to 15% travel.

Responsibilities

• Set basic in-process quality standards and lead development of testing, sampling, and training methods.
• Evaluate production processes and recommend improvements; manage design control files and CE technical documentation.
• Lead supplier qualifications, CAPA activities, and supplier quality improvement programs.

Skills

Attention to detail

Project management

Analytical thinking

Problem solving

Education

Bachelor’s degree in Engineering/Science/Math

Tools

MS Office Suite

Microsoft Excel (Advanced)

Job description

Medline Industries, LP in Chicago seeks a quality engineer to set basic in-process quality standards and lead development of testing, sampling, and training methods. You will evaluate production processes, recommend improvements, and manage design control files and CE technical documents.

You will collaborate with suppliers, perform CAPAs, support 510(k) submissions, and ensure compliance with 21 CFR 820 and ISO 13485.