Quality Engineer: Process Optimization & CAPA Leader

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Disability insurance

Job summary

Medline Industries, LP in Chicago seeks a quality-focused professional to set basic quality standards and lead testing method development. You will design experiments, apply SPC, and drive improvements across processes and products.

You will collaborate with suppliers on CAPA programs, contribute to design control and CE documentation, and ensure regulatory compliance, with travel up to 15% as needed.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
• Intermediate Excel skills (conditional formatting, tables, formulas, charting).
• Working knowledge of 21 CFR 820 and ISO13485.
• Knowledge of SPC methods and statistical data analysis.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments to understand variation and apply SPC to analyze data.
• Conduct product testing, analyze reports and defects to drive corrective actions.
• Lead supplier quality activities and CAPA/SCAR programs with suppliers.
• Provide quality expertise in product development, design control, risk management, and CE files; coordinate testing with labs.

Skills

MS Office Suite

Excel (intermediate)

Quality control

SPC knowledge

Problem solving

Time management

Education

Bachelor's degree in Engineering, Science, Math or related technical field

Tools

MS Office Suite

Job description

Medline Industries, LP in Chicago seeks a quality-focused professional to set basic quality standards and lead testing method development. You will design experiments, apply SPC, and drive improvements across processes and products.

You will collaborate with suppliers on CAPA programs, contribute to design control and CE documentation, and ensure regulatory compliance, with travel up to 15% as needed.