Quality Engineer: Process Control & CAPA Leader

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 professional to set basic quality standards during in-process stages while leading methods for testing, sampling and training. You will evaluate production processes, recommend improvements, qualify vendors, generate DMRs and CE technical files.

Responsibilities include implementing SPC, designing experiments, conducting product testing, analyzing defects, leading CAPA activities, and ensuring compliance with 21 CFR 820 and ISO13485 across global

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 2 years of experience in Quality or Engineering.
• Familiarity with quality assurance codes and standards (21 CFR 820, ISO13485).
• Ability to work with limited supervision and manage multiple projects.

Responsibilities

• Develop and implement methods for process control and inspection.
• Design experiments to understand variation sources.
• Apply SPC to analyze data and guide improvements.
• Lead CAPA investigations and supplier quality activities.
• Prepare product documentation and support 510K submissions.

Skills

SPC knowledge

Problem solving

Time management

MS Office

Excel (advanced)

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office Suite

Microsoft Excel

21 CFR 820

ISO 13485

Job description

Medline Industries, LP in Chicago seeks a quality professional to set basic quality standards during in-process stages while leading methods for testing, sampling and training. You will evaluate production processes, recommend improvements, qualify vendors, generate DMRs and CE technical files.

Responsibilities include implementing SPC, designing experiments, conducting product testing, analyzing defects, leading CAPA activities, and ensuring compliance with 21 CFR 820 and ISO13485 across global