Quality Engineer - Med Device, CAPA & Process Validation

Construction Job Board USA; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Job summary

Medline Industries, LP in the United States seeks a quality professional to set basic in‑process quality standards and lead methods for testing, sampling and training. You will evaluate production processes, recommend improvements, qualify suppliers, and generate DMRs, product specifications and CE technical files.

The role involves designing experiments, applying SPC, coordinating CAPA activities, ensuring compliance with 21 CFR 820 and ISO13485, and supporting 510K submissions.

Qualifications

• Education: Bachelor's degree in Engineering, Science, Math or related field (minimum).
• At least 2 years in Quality or Engineering.
• Experience with MS Office and Excel.
• Knowledge of 21 CFR 820 and ISO13485.

Responsibilities

• Develop and implement methods for process control, validation and inspection.
• Design experiments and apply SPC to analyze data and guide decisions.
• Lead CAPA investigations and supplier quality improvements.
• Prepare Device Master Records and CE technical files.

Skills

Problem solving

Time management

Attention to detail

Education

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

Tools

Microsoft Excel

MS Office Suite

21 CFR 820

ISO13485

Job description

Medline Industries, LP in the United States seeks a quality professional to set basic in‑process quality standards and lead methods for testing, sampling and training. You will evaluate production processes, recommend improvements, qualify suppliers, and generate DMRs, product specifications and CE technical files.

The role involves designing experiments, applying SPC, coordinating CAPA activities, ensuring compliance with 21 CFR 820 and ISO13485, and supporting 510K submissions.