Senior Engineer, Quality

Medline Industries, LP

Sr Engineer Quality at Medline ensuring compliance with quality standards in Medical Devices. Collaborating on product development and supplier management in a hybrid working model.

Posted 5/20/2026full-timeChicago • Illinois • 🇺🇸 United StatesSenior💰 $101,000 - $152,000 per yearWebsite

About the role

Key responsibilities & impact

Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design complex experiments to understand sources of variation affecting products and processes.
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.
Direct and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier quality improvement programs.
Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations.

Requirements

What you’ll need

Bachelor’s degree in Engineering, Science, Math or other related technical field
4+ years of experience in the Quality or Engineering
Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards)
Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting)
Experience leading a team to accomplish cross-functional goals

Benefits

Comp & perks

health insurance
life and disability
401(k) contributions
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

process controlprocess validationprocess improvementstatistical process controlexperimental product testingdata analysiscorrective actionsrisk managementproduct documentationquality assurance

Soft Skills

leadershipcollaborationproblem-solvingcommunicationteam management