Senior Quality Engineer: SPC, CAPA & Supplier Quality

Medline Industries, Inc. in; 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 an experienced Quality Engineer to set basic quality standards and lead development of testing, sampling and training methods. You will evaluate production processes, recommend improvements, manage vendor qualifications, and maintain DMRs, product specs, and design control files.

The role requires building CE technical files, coordinating with Regulatory and Suppliers, and driving CAPA for continuous quality improvement. Travel up to 15% is possible.

Qualifications

• Bachelor's degree in Engineering, Science, Math or other related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government/industry QA codes (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Ability to work independently with minimal supervision and escalate when needed.
• Strong time management to juggle multiple projects.

Responsibilities

• Develop and implement methods and procedures for process control, validation, improvement, testing, and inspection.
• Design experiments to understand variation in products and processes.
• Apply SPC to analyze data and steer process changes.
• Perform product testing and analysis to maintain quality and minimize defects.
• Lead supplier qualifications and CAPA/SCAR activities.
• Coordinate product testing with internal and external labs as required.
• Ensure compliance with domestic and international regulations for product lines.
• Lead investigations of non-conformances and drive corrective actions.

Skills

Quality engineering

Statistical analysis

MS Office (Excel)

Project leadership

Time management

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office

Excel (Advanced)

Pivot tables

Job description

Medline Industries, LP is seeking an experienced Quality Engineer to set basic quality standards and lead development of testing, sampling and training methods. You will evaluate production processes, recommend improvements, manage vendor qualifications, and maintain DMRs, product specs, and design control files.

The role requires building CE technical files, coordinating with Regulatory and Suppliers, and driving CAPA for continuous quality improvement. Travel up to 15% is possible.