Senior Quality Engineer, Medical Devices & Process

Medline Industries; United States; 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 seeks a quality-focused professional to independently set basic quality standards for in-process activities and to lead development of testing, sampling and training methods. You will evaluate production processes and drive improvements while managing vendor quality programs.

The role requires designing experiments, applying SPC, and leading CAPA investigations; you will coordinate with regulatory teams on design control, risk management and CE technical files.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• At least 4 years of quality or engineering experience.
• Experience with government/industry quality standards (e.g., 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR).
• Experience applying Six Sigma/Lean concepts is a plus.

Responsibilities

• Set basic quality standards for in-process and lead method development for testing, sampling and training.
• Design experiments and apply SPC to understand variation and drive improvements.
• Lead CAPA, supplier qualifications and supplier quality improvement programs.
• Develop and maintain design control, risk management and CE technical files with Regulatory groups.
• Coordinate product testing with internal/external labs and ensure regulatory compliance.

Skills

SPC

CAPA

Vendor management

Quality assurance

Regulatory knowledge

Excel

Leadership

Problem solving

Education

Bachelor's degree in Engineering or Science

Tools

Microsoft Excel

PowerPoint

Job description

Medline Industries seeks a quality-focused professional to independently set basic quality standards for in-process activities and to lead development of testing, sampling and training methods. You will evaluate production processes and drive improvements while managing vendor quality programs.

The role requires designing experiments, applying SPC, and leading CAPA investigations; you will coordinate with regulatory teams on design control, risk management and CE technical files.