Quality Engineer - Anesthesia Devices

Medline Industries, Inc.; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality/Engineering professional to set basic quality standards and lead methods for testing, sampling, and training. You will evaluate production processes, qualify vendors, and maintain DMRs and CE/510K documentation.

The role involves problem solving, CAPA leadership, and collaboration with regulatory groups to ensure compliant device documentation and quality control across programs.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field required.

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, improvement, testing, and inspection to ensure products are ideal and functional.
• Design experiments to understand variation sources using SPC to evaluate processes and changes.
• Perform product testing and analysis to maintain quality and minimize defects; generate reports and determine trends.
• Coordinate with supplier representatives on quality issues; implement CAPA and SCAR; lead supplier qualifications.
• Provide quality expertise in Product Development, Design Control, Risk Management, and CE Technical Files.
• Build device master records and quality documentation per regulations; collaborate with Regulatory and Suppliers for 510K submissions.
• Coordinate product testing with internal and external labs as required.
• Ensure compliance with domestic/international regulations; review design documentation and vendor quality documents.
• Lead investigations of non-conformances and develop CAPA.

Skills

Process control

SPC (statistical process control)

CAPA

Quality systems

Vendor management

Regulatory knowledge

Data analysis

MS Office

Time management

Problem solving

Education

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

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking a Quality/Engineering professional to set basic quality standards and lead methods for testing, sampling, and training. You will evaluate production processes, qualify vendors, and maintain DMRs and CE/510K documentation.

The role involves problem solving, CAPA leadership, and collaboration with regulatory groups to ensure compliant device documentation and quality control across programs.