Senior Manufacturing Quality Engineer - Medical Devices

Medline; Town of Hartland (WI); Presencial; USD 101.000 - 152.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Descripción de la vacante

Medline Industries, LP in Hartland, WI seeks a Senior Manufacturing Quality Engineer to set basic quality standards and lead testing, sampling and training initiatives across production lines.

You will design experiments, apply SPC, manage DMRs and product specifications, and collaborate with suppliers and regulatory groups to ensure CE and FDA compliance. Travel up to 15% may be required.

Strong problem solving, leadership, and documentation skills are essential for success in this role.

Formación

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government/industry quality codes (e.g., 21 CFR 820, ISO13485, 21 CFR 210/211).

Responsabilidades

• Develop and implement methods for process control and validation.
• Design experiments to understand variation and apply SPC.
• Lead supplier qualifications and CAPA/SCAR activities.
• Prepare and maintain design control and CE technical files.
• Coordinate product testing with internal/external labs.

Conocimientos

Problem solving

Team leadership

Time management

Cross-functional collaboration

Educación

Bachelor's degree in Engineering

Herramientas

Microsoft Excel

Descripción del empleo

Medline Industries, LP in Hartland, WI seeks a Senior Manufacturing Quality Engineer to set basic quality standards and lead testing, sampling and training initiatives across production lines.

You will design experiments, apply SPC, manage DMRs and product specifications, and collaborate with suppliers and regulatory groups to ensure CE and FDA compliance. Travel up to 15% may be required.

Strong problem solving, leadership, and documentation skills are essential for success in this role.