Quality Engineer: Process Excellence & Compliance

Regulatory Jobs; Chicago (IL); Vor Ort; USD 79.000 - 119.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline Industries, LP is seeking a Quality Engineer to set basic quality standards and lead methods for testing, sampling, and training. You will evaluate production processes, implement improvements, manage vendors, and generate essential quality documentation including DMRs and CE/510(k) support.

You will collaborate with Regulatory and Suppliers to ensure compliance with 21 CFR 820 and ISO13485, perform CAPA investigations, and lead investigations into non-conformances while driving

Qualifikationen

• Bachelor’s degree in a technical field is typically required.
• At least 2 years of experience in Quality or Engineering.
• Experience with SPC, quality systems, and regulatory standards (e.g., 21 CFR 820).

Aufgaben

• Establish and maintain quality standards for in-process and finished products.
• Design experiments and apply SPC to analyze data and improve processes.
• Lead CAPA/SCAR activities and supplier quality improvements.
• Prepare and maintain DMRs, device master records, and design histories as required.
• Coordinate product testing with internal and external labs and support 510(k) submissions.
• Ensure compliance with domestic and international regulations for product lines.

Kenntnisse

Quality engineering

CAPA

Process validation

Vendor management

MS Office

Ausbildung

Bachelor's degree in Engineering/Science

Tools

MS Office Suite

ISO13485

Jobbeschreibung

Medline Industries, LP is seeking a Quality Engineer to set basic quality standards and lead methods for testing, sampling, and training. You will evaluate production processes, implement improvements, manage vendors, and generate essential quality documentation including DMRs and CE/510(k) support.

You will collaborate with Regulatory and Suppliers to ensure compliance with 21 CFR 820 and ISO13485, perform CAPA investigations, and lead investigations into non-conformances while driving