Senior Quality Engineer: Process Control & CAPA Leader

Medline Industries; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP seeks a quality professional to develop and implement methods for process control, validation, testing, and inspection to ensure products are reliable and compliant.

You will design complex experiments to understand sources of variation, apply SPC, generate reports on defects, lead CAPA and SCAR investigations, and coordinate with suppliers for qualifications and CE/510K documentation. Position requires up to 15% travel.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.

Responsibilities

• Develop and implement methods for process control, validation, testing and inspection to ensure compliant products.
• Design experiments to understand sources of variation and apply SPC to evaluate processes.
• Lead CAPA/SCAR investigations and coordinate with suppliers for qualifications and improvements.
• Prepare and maintain device master records, design history files and CE technical files as required.

Skills

Statistical analysis

CAPA

Process improvement

Project management

MS Excel Advanced

Education

Bachelor’s degree in Engineering, Science, Math

Tools

MS Office Suite

Job description

Medline Industries, LP seeks a quality professional to develop and implement methods for process control, validation, testing, and inspection to ensure products are reliable and compliant.

You will design complex experiments to understand sources of variation, apply SPC, generate reports on defects, lead CAPA and SCAR investigations, and coordinate with suppliers for qualifications and CE/510K documentation. Position requires up to 15% travel.