Senior Quality Engineer – Medical Devices, Design Control

Medline International Two Australia Pty; Chicago (IL); Hybrid; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Chicago, IL is seeking a Senior Quality Engineer to set basic quality standards and lead testing, sampling and training initiatives across in-process and finished products. You will design experiments, apply SPC, collaborate with suppliers, manage CAPA/SCAR, and contribute to regulatory submissions and CE files.

Responsibilities include coordinating testing with internal and external labs, ensuring compliance with 21 CFR 820/ISO13485, and driving quality improvements

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• Experience with government/industry QA codes and standards (21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Ability to work with minimal supervision and escalate when needed.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design complex experiments; apply SPC to analyze data and guide decisions.
• Lead supplier quality activities, CAPA/SCAR and supplier qualifications.
• Prepare Design Control, Risk Management, and CE Technical Files; support 510K submissions.
• Coordinate testing with internal and external labs and ensure regulatory compliance.

Skills

SPC

CAPA

Problem solving

Advanced MS Excel

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Science/Math

Tools

MS Office Suite

Microsoft Excel advanced

Job description

Medline Industries, LP in Chicago, IL is seeking a Senior Quality Engineer to set basic quality standards and lead testing, sampling and training initiatives across in-process and finished products. You will design experiments, apply SPC, collaborate with suppliers, manage CAPA/SCAR, and contribute to regulatory submissions and CE files.

Responsibilities include coordinating testing with internal and external labs, ensuring compliance with 21 CFR 820/ISO13485, and driving quality improvements