Quality Engineer – Medical Devices, Design Control & CAPA

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

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality professional to independently set basic quality standards for in-process and lead methods for testing, sampling and training.

You will evaluate production processes, propose improvements and manage vendor qualification, DMRs, product specs, and design control files.The role requires collaboration with Regulatory Groups and Suppliers for 510K submissions, CAPA leadership, and ensuring compliance with 21 CFR 820 and ISO13485.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience with design control, CAPA, and regulatory standards (21 CFR 820, ISO13485).
• Strong MS Office and Excel skills; ability to work with cross-functional teams.

Responsibilities

• Develop and implement methods for process control, validation, testing and inspection.
• Design experiments and apply SPC to analyze data and drive improvements.
• Lead supplier quality activities, CAPA/SCAR and supplier qualifications.
• Prepare and maintain Device Master Records, 510K submissions, and design documents.
• Coordinate product testing with labs and ensure compliance with regulations.

Skills

Time management

Problem solving

Attention to detail

Analytical thinking

MS Office proficiency

Education

Bachelor’s degree in Engineering/Science/Math or related field

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries, LP is seeking a quality professional to independently set basic quality standards for in-process and lead methods for testing, sampling and training.

You will evaluate production processes, propose improvements and manage vendor qualification, DMRs, product specs, and design control files.The role requires collaboration with Regulatory Groups and Suppliers for 510K submissions, CAPA leadership, and ensuring compliance with 21 CFR 820 and ISO13485.