Senior Quality Engineer, Surgical OR Systems

Medline Industries, LP; Chicago (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 in Illinois seeks a Quality Engineering professional to independently set basic quality standards for in-process testing and to develop methods for testing, sampling and training. You will evaluate production processes, qualify and manage vendors, and maintain DMRs, product specs, design control files, and CE technical files.

Key responsibilities include leading SPC, CAPA activities, supplier qualifications, and collaboration on 510K submissions and regulatory files.

Qualifications

• Bachelor’s degree in Engineering/Science/Math or related field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government/industry quality codes and standards (e.g., 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Strong MS Office skills, especially advanced Excel (Pivot tables, conditional formatting, formulas).

Responsibilities

• Manage development and implementation of methods for process control, validation, and inspection.
• Design complex experiments to understand sources of variation.
• Apply SPC methods to analyze data and guide process improvements.
• Lead supplier qualifications and CAPA activities; drive corrective actions.
• Coordinate product testing with internal and external laboratories.
• Assist in preparing 510K submissions and CE technical files.

Skills

Quality leadership

SPC

CAPA

Supplier management

Advanced Excel

MS Office

Problem solving

Time management

Travel

Education

Bachelor's degree in Engineering/Science/Math

Job description

Medline Industries, LP in Illinois seeks a Quality Engineering professional to independently set basic quality standards for in-process testing and to develop methods for testing, sampling and training. You will evaluate production processes, qualify and manage vendors, and maintain DMRs, product specs, design control files, and CE technical files.

Key responsibilities include leading SPC, CAPA activities, supplier qualifications, and collaboration on 510K submissions and regulatory files.