Senior Quality Engineer: Medical Devices & SPC Leader

Medline Industries, Inc.; Northfield (MN); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Quality/Engineering professional to set basic quality standards and develop testing, sampling, and training methods. You will oversee process control, validation, and supplier quality programs while producing DMRs, design control files, and CE technical files.

You will design complex experiments leveraging SPC to understand variation, lead CAPA activities, and collaborate with suppliers.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 4 years of experience in Quality or Engineering and familiarity with government/industry quality codes (e.g., 21 CFR 820, ISO13485).
• Strong problem-solving and data analysis skills; experience with SPC and design of experiments.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments to identify sources of variation and apply SPC to evaluate processes.
• Lead CAPA investigations and supplier quality improvements; manage supplier qualifications.
• Create and maintain design control files, DMRs and CE technical files; coordinate testing with labs.

Skills

SPC methods

CAPA

Problem solving

Cross-functional leadership

Time management

MS Office proficiency

Travel ready

Education

Bachelor’s degree in Engineering/Science/Math or related technical field

Tools

MS Excel

Job description

Medline Industries, LP seeks a Quality/Engineering professional to set basic quality standards and develop testing, sampling, and training methods. You will oversee process control, validation, and supplier quality programs while producing DMRs, design control files, and CE technical files.

You will design complex experiments leveraging SPC to understand variation, lead CAPA activities, and collaborate with suppliers.