Senior Quality Engineer, Medical Devices | CAPA & Process Lead

Medline Industries, Inc. in; Town of Hartland (WI); 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 in the United States seeks a Quality/Engineering professional to independently set basic quality standards and lead methods for testing, sampling, and training. You will manage process control, validation and supplier collaboration to ensure compliant products and robust CAPA actions.

Responsibilities include designing experiments, applying SPC, and maintaining 510K-related documents.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying knowledge of government and industry quality codes (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, ANSI/AAMI/ISO sterilization).
• Strong problem solving and time management skills.
• Ability to lead cross-functional teams and CAPA programs.

Responsibilities

• Develop and implement methods for process control and validation.
• Design experiments to understand variation and analyze SPC data.
• Lead supplier qualifications and CAPA actions.
• Prepare DMRs, design control files and CE Technical Files.
• Support 510K submissions and regulatory documentation.
• Collaborate with labs and regulatory teams.

Skills

Time management

MS Office

Problem solving

Cross-functional teamwork

SPC

Quality assurance

Education

Bachelor’s degree in Engineering

Tools

Microsoft Excel

Job description

Medline Industries, LP in the United States seeks a Quality/Engineering professional to independently set basic quality standards and lead methods for testing, sampling, and training. You will manage process control, validation and supplier collaboration to ensure compliant products and robust CAPA actions.

Responsibilities include designing experiments, applying SPC, and maintaining 510K-related documents.