Quality Engineer - Medical Devices & Regulatory Compliance

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-focused professional to independently set basic quality standards for in-process and lead methods for testing, sampling and training. You will evaluate production processes, recommend improvements, manage vendor qualification and maintain DMRs and CE technical files.

The role requires design of experiments, SPC expertise, and collaboration with regulatory groups to ensure compliance with 21 CFR 820 and ISO13485.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field is typically required.
• 2+ years of experience in Quality or Engineering.
• Experience with government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485) preferred.

Responsibilities

• Manage development and implementation of methods for process control, validation, testing, and inspection to ensure product quality.
• Design experiments to understand variation sources and guide process decisions using SPC methods.
• Lead CAPA, SCAR and supplier quality improvements; coordinate supplier qualifications and non-conformance investigations.
• Prepare and maintain product documentation and support 510K submissions and CE technical files.

Skills

Statistical process control

Design of experiments

CAPA

Vendor management

Problem solving

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Sciences

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries, LP in Chicago seeks a quality-focused professional to independently set basic quality standards for in-process and lead methods for testing, sampling and training. You will evaluate production processes, recommend improvements, manage vendor qualification and maintain DMRs and CE technical files.

The role requires design of experiments, SPC expertise, and collaboration with regulatory groups to ensure compliance with 21 CFR 820 and ISO13485.