Senior Quality Engineer – Med Devices, CAPA & SPC

Regulatory Jobs; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a quality professional to independently set basic quality standards for in‑process activities and lead efforts to develop testing, sampling, and training methods. You will evaluate production processes, qualify and manage vendor quality, and generate DMRs and CE technical files to support regulatory submissions.

You will lead investigations, build documentation, and collaborate with Regulatory Groups to produce 510K submissions.

Qualifications

• Experience 4+ years in Quality or Engineering.
• Experience applying government/industry QA codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO sterilization).
• Ability work with limited supervision and meet deadlines.

Responsibilities

• Develop and implement methods and procedures for process control and validation.
• Design experiments to understand variation and apply SPC methods.
• Perform product testing and analysis to maintain quality and reduce defects.
• Lead supplier qualifications and collaborate on CAPA/SCAR.
• Prepare Device Master Records and CE technical files; assist with 510K submissions.
• Ensure compliance with domestic and international regulations; review design documentation.
• Lead investigations of non-conformances and implement corrective actions.
• Train team members on processes and best practices; act as Quality lead when needed.

Skills

MS Office Suite

Microsoft Excel

Six Sigma/Lean

Leadership

Time management

Problem solving

Education

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

Job description

Medline Industries, LP seeks a quality professional to independently set basic quality standards for in‑process activities and lead efforts to develop testing, sampling, and training methods. You will evaluate production processes, qualify and manage vendor quality, and generate DMRs and CE technical files to support regulatory submissions.

You will lead investigations, build documentation, and collaborate with Regulatory Groups to produce 510K submissions.