Quality Engineer – Medical Devices, CAPA & Compliance

RiseMe; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Job summary

Medline Industries, LP in Chicago seeks a quality professional to set basic quality standards, develop testing methods, and manage documentation including DMRs, product specifications, design control files, and CE technical files.

You will drive process control, validation, CAPA, supplier qualifications, and ensure compliance with 21 CFR 820 and ISO 13485, with up to 15% travel. This role requires a technical degree and 2+ years in quality/engineering.

Qualifications

• Bachelor’s degree in a technical field required.
• At least 2 years in Quality or Engineering.
• Experience with SPC, testing, and process validation preferred.
• Knowledge of 21 CFR 820 and ISO 13485 is beneficial.

Responsibilities

• Develop and implement methods for process control, validation, testing, and inspection to ensure product quality.
• Design experiments to understand sources of variation and apply SPC to analyze data.
• Collaborate with suppliers on quality problems; lead CAPA and SCAR activities.
• Provide quality expertise in product development, design control, risk management, and CE files; prepare DMRs and 510(k) submissions as needed.
• Perform design/document reviews for regulatory compliance and coordinate product testing with labs.

Skills

Independent work

Time management

Problem solving

MS Office

Excel advanced

Quality standards knowledge

Travel up to 15%

Education

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

Job description

Medline Industries, LP in Chicago seeks a quality professional to set basic quality standards, develop testing methods, and manage documentation including DMRs, product specifications, design control files, and CE technical files.

You will drive process control, validation, CAPA, supplier qualifications, and ensure compliance with 21 CFR 820 and ISO 13485, with up to 15% travel. This role requires a technical degree and 2+ years in quality/engineering.