Senior Quality Engineer – SPC, CAPA & Compliance

Medline Industries, Inc.; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Medline Industries, LP seeks a Quality Engineer to set basic quality standards and lead the development of testing and sampling methods. You will evaluate production processes, drive improvements, and manage vendor qualifications while maintaining regulatory documentation.

The role requires 4+ years in quality or engineering, strong Excel skills, and the ability to travel up to 15%. You will collaborate cross-functionally and lead CAPA initiatives to ensure compliance with 21 CFR 820 and

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 4 years of experience in Quality or Engineering.
• Experience with QA codes/standards (21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Ability to work with little supervision and manage multiple projects.
• Proficient in MS Office, especially Excel.
• Travel up to 15%.

Responsibilities

• Develop and implement methods for process control, validation, testing and inspection.
• Design experiments and apply SPC to analyze data and drive improvements.
• Lead CAPA, SCAR and supplier quality initiatives; manage supplier qualifications.
• Create and maintain design history and regulatory documentation (DMR, CE, 510K related).
• Coordinate testing with internal/external labs and ensure regulatory compliance.
• Investigate non-conformances and lead corrective actions.
• Train team members on processes and act as Quality lead when needed.

Skills

Quality engineering

Statistical analysis

Leadership

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Science, Math

Tools

Excel

Word

PowerPoint

Outlook

MS Office Suite

Job description

Medline Industries, LP seeks a Quality Engineer to set basic quality standards and lead the development of testing and sampling methods. You will evaluate production processes, drive improvements, and manage vendor qualifications while maintaining regulatory documentation.

The role requires 4+ years in quality or engineering, strong Excel skills, and the ability to travel up to 15%. You will collaborate cross-functionally and lead CAPA initiatives to ensure compliance with 21 CFR 820 and