Medical Device Quality Engineer — SPC, CAPA & CE

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

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Chicago seeks a quality leader to set basic quality standards for in-process activities and to develop methods for testing, sampling, and training to ensure products meet specifications.

You will design experiments, apply SPC, coordinate CAPA, manage supplier qualifications, and prepare design control documents and 510K materials to support development and manufacturing.

Qualifications

• Bachelor's degree in Engineering or related field.
• At least 2 years of experience in Quality or Engineering.
• Experience with 21 CFR 820 and ISO13485.
• Ability to develop CAPA and investigations.

Responsibilities

• Develop methods for process control, validation, testing, and inspection to ensure products are reliable and functional.
• Design experiments to study variation; apply SPC to evaluate processes and changes.
• Lead supplier quality improvements and CAPA investigations.
• Coordinate product testing with internal/external labs and maintain regulatory documents.

Skills

Independent work

Time management

Problem solving

MS Office

Excel advanced

Quality standards

Regulatory knowledge

Education

Bachelor's degree in engineering/science

Job description

Medline Industries, LP in Chicago seeks a quality leader to set basic quality standards for in-process activities and to develop methods for testing, sampling, and training to ensure products meet specifications.

You will design experiments, apply SPC, coordinate CAPA, manage supplier qualifications, and prepare design control documents and 510K materials to support development and manufacturing.