Senior Quality Engineer, OR Division: Process & Compliance

Medline; Chicago, Northern (IL, KY); Hybrid; USD 101,000 - 152,000; Full time

Job summary

Medline in Chicago seeks a quality/engineering professional to independently set basic quality standards for in-process and product testing, sampling, and training; lead methods for testing and design control files.

You will coordinate with suppliers, manage CAPA, generate DMRs, CE files, and ensure compliance with 21 CFR 820 and ISO13485; requires 4+ years in quality or engineering. Travel up to 15% may be needed, with a salary range of $101,000 to $152,000 plus bonus eligibility.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying government/industry quality codes (e.g. 21 CFR 820, ISO13485).

Responsibilities

• Develop and implement methods for process control, validation, testing, and inspection.
• Lead CAPA, SCAR investigations and drive corrective actions.
• Collaborate with suppliers on quality issues and supplier qualifications.
• Prepare and maintain design control and CE/510k documentation as required.

Skills

Quality/Engineering leadership

Advanced Excel

SPC

MS Office Suite

Problem solving

Education

Bachelor’s degree in Engineering/Science/Math

Job description

Medline in Chicago seeks a quality/engineering professional to independently set basic quality standards for in-process and product testing, sampling, and training; lead methods for testing and design control files.

You will coordinate with suppliers, manage CAPA, generate DMRs, CE files, and ensure compliance with 21 CFR 820 and ISO13485; requires 4+ years in quality or engineering. Travel up to 15% may be needed, with a salary range of $101,000 to $152,000 plus bonus eligibility.