Senior Quality Engineer MedTech (SPC, CAPA, CE Files)

Medline; Chicago, Northern (IL, KY); Hybrid; USD 101,000 - 152,000; Full time

Job summary

Medline is seeking a Sr Engineer Quality in Chicago, IL, offering a hybrid, full-time position. You will set quality standards for in-process and testing activities, and lead methods for sampling, training, and process improvements.

You will design experiments, apply SPC, manage CAPA/SCAR with suppliers, and coordinate 510K submissions and testing with internal and external labs while ensuring compliance with 21 CFR 820, ISO 13485, and related standards.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).

Responsibilities

• Develop and implement methods for process control, validation, and inspection.
• Design experiments and apply SPC to analyze data and guide decisions.
• Lead supplier qualifications and CAPA/SCAR efforts.
• Prepare and review design documentation and CE technical files.
• Coordinate product testing with internal and external laboratories.

Skills

SPC knowledge

CAPA/SCAR leadership

MS Excel advanced

Time management

Team leadership

Problem solving

Education

Bachelor’s degree in Engineering/Science/Math

Tools

Microsoft Excel

MS Office Suite

Job description

Medline is seeking a Sr Engineer Quality in Chicago, IL, offering a hybrid, full-time position. You will set quality standards for in-process and testing activities, and lead methods for sampling, training, and process improvements.

You will design experiments, apply SPC, manage CAPA/SCAR with suppliers, and coordinate 510K submissions and testing with internal and external labs while ensuring compliance with 21 CFR 820, ISO 13485, and related standards.