Senior Quality Engineer - Medical Devices Lead

Medline Industries, LP; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Illinois seeks a quality professional to set basic in-process quality standards and lead testing method development, sampling and training. You will evaluate production processes, qualify vendors, maintain DMRs and CE files, and collaborate with regulatory teams to support 510K submissions.

The role requires at least 4 years in quality or engineering, knowledge of 21 CFR 820 and ISO13485, and strong Excel skills. Travel up to 15% is expected.

Qualifications

• Bachelor’s degree in a technical field.
• 4+ years in Quality or Engineering with QA/QC experience.
• Familiarity with government and industry quality codes and standards.

Responsibilities

• Develop methods and procedures for process control and validation.
• Design experiments using SPC to analyze variation and drive improvements.
• Perform product testing, analyze results, and lead CAPA investigations.
• Collaborate with suppliers on quality issues and lead supplier qualifications.
• Create and maintain Device Master Records and CE technical files.
• Ensure regulatory compliance and support 510K submissions.
• Train team members on processes and best practices and act as Quality lead when needed.

Skills

Quality engineering

Process control

SPC

CAPA

SCAR

Design of experiments

Vendor management

Regulatory knowledge

MS Office

Advanced Excel

Time management

Leadership

Problem solving

Travel coordination

Education

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

Tools

Microsoft Office

Excel

Job description

Medline Industries, LP in Illinois seeks a quality professional to set basic in-process quality standards and lead testing method development, sampling and training. You will evaluate production processes, qualify vendors, maintain DMRs and CE files, and collaborate with regulatory teams to support 510K submissions.

The role requires at least 4 years in quality or engineering, knowledge of 21 CFR 820 and ISO13485, and strong Excel skills. Travel up to 15% is expected.