Senior Quality Engineer - Med Devices & CAPA Leader

Medline; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality professional to set basic in-process quality standards and lead testing method development. Under minimal supervision you’ll generate device master records, CE files, and design control documents.

You will design complex experiments, apply SPC, and collaborate with suppliers on CAPA and SCAR initiatives. The role requires a Bachelor’s in engineering or related field and at least 4 years in quality or engineering, with deep knowledge of regulatory codes.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 4 years in Quality or Engineering.
• Experience with government and industry quality codes (e.g. 21 CFR 820, ISO13485).

Responsibilities

• Develop and implement methods for process control, validation, and inspection.
• Design experiments using SPC to analyze variation in products and processes.
• Lead CAPA investigations and supplier qualifications with corrective actions.
• Coordinate product testing and maintain DMRs and design control files.
• Mentor team members and act as Quality lead when needed.

Skills

Time management

Problem solving

Team leadership

MS Office

Advanced Excel

Education

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

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking a quality professional to set basic in-process quality standards and lead testing method development. Under minimal supervision you’ll generate device master records, CE files, and design control documents.

You will design complex experiments, apply SPC, and collaborate with suppliers on CAPA and SCAR initiatives. The role requires a Bachelor’s in engineering or related field and at least 4 years in quality or engineering, with deep knowledge of regulatory codes.