Quality Engineer - Process Control & CAPA Lead

Medline Industries, LP; Chicago (IL); On-site; USD 71,000 - 119,000; Full time

Job summary

Medline Industries, LP is seeking a quality professional to independently set basic quality standards for in-process activities and lead efforts to develop testing, sampling and training methods.

You will evaluate production processes, qualify vendors, manage DMRs and design control files, support 510K submissions and CE technical files, coordinate testing with labs, and drive CAPA and supplier quality programs to ensure compliant products.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience with regulatory standards (ISO 13485, 21 CFR 820).
• Experience in process control and statistical methods.
• Ability to travel up to 15%.

Responsibilities

• Develop methods and procedures for process control, validation, improvement and inspection.
• Design experiments and apply SPC to evaluate processes.
• Perform product testing and analyze data to drive CAPA.
• Collaborate with suppliers on CAPA and supplier quality programs.
• Prepare Device Master Records and support 510K submissions.
• Coordinate testing with internal/external labs.
• Ensure compliance with domestic and international regulations.
• Lead investigations of non-conformances and implement CAPA.

Skills

SPC

CAPA

Vendor management

Regulatory compliance

MS Excel

MS Office

Problem solving

Education

Bachelor's degree in Engineering or Science

Tools

ISO 13485

21 CFR 820

Job description

Medline Industries, LP is seeking a quality professional to independently set basic quality standards for in-process activities and lead efforts to develop testing, sampling and training methods.

You will evaluate production processes, qualify vendors, manage DMRs and design control files, support 510K submissions and CE technical files, coordinate testing with labs, and drive CAPA and supplier quality programs to ensure compliant products.