Senior Quality Engineer: Process & Design Control

Medline; Chicago (IL); On-site; USD 101,000 - 152,000; 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 Engineer to set basic quality standards across in-process activities and lead method development for testing, sampling, and training. You will evaluate production processes, qualify vendors, maintain DMRs and CE technical files, and coordinate 510K submissions as needed.

The ideal candidate has 4+ years in Quality or Engineering, knowledge of 21 CFR 820, ISO13485 and related standards, and strong Excel skills. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in engineering, science, math or related technical field.
• Experience applying government and industry quality assurance codes and standards.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing, and inspection.
• Design experiments to understand variation and apply SPC to evaluate processes.
• Perform testing and analysis to maintain quality and minimize defects; generate reports.
• Lead supplier quality improvements; manage CAPA/SCAR and supplier qualifications.
• Provide QA expertise in Product Development, Design Control, Risk Management and CE technical files.

Skills

Statistical analysis

SPC

CAPA

Quality management

Leadership

Time management

MS Office

Advanced Excel

Education

Bachelor’s degree in Engineering/Science/Math

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries, LP is seeking a Quality Engineer to set basic quality standards across in-process activities and lead method development for testing, sampling, and training. You will evaluate production processes, qualify vendors, maintain DMRs and CE technical files, and coordinate 510K submissions as needed.

The ideal candidate has 4+ years in Quality or Engineering, knowledge of 21 CFR 820, ISO13485 and related standards, and strong Excel skills. Travel up to 15% may be required.