Quality Engineer - Medical Devices & Compliance

Medline Industries, Inc.; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP, based in Chicago, IL, is seeking a Quality Engineer to set basic quality standards and lead testing, sampling and training efforts within a GMP/compliant framework. Under broad supervision, you will evaluate production processes, design experiments, manage supplier quality programs including CAPA/SCAR, and prepare device master records and regulatory submissions as required.

Travel up to 15% and a Bachelor's in engineering or related field with 2+ years in

Qualifications

• Bachelor’s degree in a technical field.
• Experience with quality systems and regulatory requirements.
• Proficient in MS Office (Word, Excel, PowerPoint, Outlook).
• Intermediate Excel skills (conditional formatting, tables, formulas, charting).
• Familiarity with 21 CFR 820 and ISO13485.
• Strong time management to handle multiple projects.

Responsibilities

• Manage development and implementation of methods for process control, validation, testing and inspection.
• Design experiments to understand sources of variation and apply SPC.
• Coordinate supplier quality efforts, CAPA/SCAR, and supplier qualifications.
• Provide Quality expertise in Product Development, Design Control and CE files; prepare device documentation.
• Ensure regulatory compliance and perform design documentation reviews.
• Lead investigations of non-conformances and implement CAPA.

Skills

Statistical analysis

SPC

CAPA

MS Excel

MS Office

Quality standards

Time management

Problem solving

Vendor management

Education

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

Job description

Medline Industries, LP, based in Chicago, IL, is seeking a Quality Engineer to set basic quality standards and lead testing, sampling and training efforts within a GMP/compliant framework. Under broad supervision, you will evaluate production processes, design experiments, manage supplier quality programs including CAPA/SCAR, and prepare device master records and regulatory submissions as required.

Travel up to 15% and a Bachelor's in engineering or related field with 2+ years in