Senior Quality Engineer: Process Excellence & CAPA Lead

Regulatory Jobs; Northfield Township (IL); On-site; 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 seeks a quality professional to set basic quality standards, lead testing and training, and manage DMRs and CE files. You will design experiments, apply SPC, and drive corrective actions.

Responsibilities include CAPA, supplier qualification, and ensuring compliance with 21 CFR/ISO13485, as well as cross‑functional collaboration to improve processes and products.

Travel up to 15% and a competitive benefits package accompany the role in Illinois.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• 4+ years in Quality or Engineering.
• Experience with 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ISO sterilization.
• Ability to work with little supervision and meet deadlines.
• Proficient with MS Office; advanced Excel skills required.

Responsibilities

• Develop and implement methods for process control, validation, and inspection.
• Design experiments; apply SPC to evaluate processes and changes.
• Conduct testing and analysis to minimize defects and guide actions.
• Lead CAPA and supplier qualifications; coordinate with suppliers.
• Support design controls, risk management, and CE technical files.
• Ensure regulatory compliance across product lines and docs.

Skills

MS Office Suite

Advanced Excel

Time management

Problem solving

Leadership

Cross-functional collaboration

Statistical analysis

Education

Bachelor’s degree in Engineering, Science, Math

Job description

Medline Industries, LP seeks a quality professional to set basic quality standards, lead testing and training, and manage DMRs and CE files. You will design experiments, apply SPC, and drive corrective actions.

Responsibilities include CAPA, supplier qualification, and ensuring compliance with 21 CFR/ISO13485, as well as cross‑functional collaboration to improve processes and products.

Travel up to 15% and a competitive benefits package accompany the role in Illinois.