Quality Engineer: Process Excellence & CAPA Leader

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Assurance/Engineer professional to set basic quality standards for in-process activities and to lead development of testing methods, sampling, and training. You will evaluate production processes, drive improvements, and manage vendor quality programs, DMRs, and CE technical files.

Responsibilities include SPC analysis, design of experiments, CAPA implementation, and collaboration on 510(k) submissions.

Qualifications

• Requires 2+ years of experience in Quality or Engineering.
• Experience with SPC, quality assurance concepts and design control is a plus.
• Proficiency in MS Office and Excel for data analysis and reporting.

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, and inspection to ensure products are ideal and functional.
• Design experiments to understand sources of variation and guide improvements.
• Apply SPC methods to analyze data and evaluate processes and changes.
• Design and perform product testing to maintain quality and minimize defects.
• Lead supplier qualifications and collaborate on CAPA/SCAR programs.
• Coordinate with Regulatory Groups and Suppliers for 510(k) submissions as required.
• Build and maintain DMRs, product specifications, and CE technical files.

Skills

SPC analysis

Quality improvement

Problem solving

Time management

MS Office

Excel

Education

Bachelor's degree in Engineering/Science/Math or related

Tools

MS Office Suite

Job description

Medline Industries, LP is seeking a Quality Assurance/Engineer professional to set basic quality standards for in-process activities and to lead development of testing methods, sampling, and training. You will evaluate production processes, drive improvements, and manage vendor quality programs, DMRs, and CE technical files.

Responsibilities include SPC analysis, design of experiments, CAPA implementation, and collaboration on 510(k) submissions.