Anesthesia Devices Quality Engineer — Drive Process Excellence

Medline Industries, Inc. in; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a Quality Engineer- Anesthesia to join our healthcare quality team in Chicago. You will independently set basic quality standards for in-process work and lead efforts to test, sample, and train.

Responsibilities include designing experiments, applying SPC, performing product testing, and coordinating CAPA with suppliers while ensuring regulatory compliance (21 CFR 820, ISO13485).

Qualifications

• Bachelor's degree in Engineering, Science, Math or other related technical field.
• 2+ years of experience in Quality or Engineering.
• Experience using SPC and statistical methods to analyze processes.
• Knowledge of 21 CFR 820 and ISO13485 quality standards.
• Capability to travel up to 15%.

Responsibilities

• Lead development and implementation of methods for process control, validation, testing, and inspection.
• Design experiments to understand variation and apply SPC to evaluate changes.
• Perform product testing and analysis to maintain quality and reduce defects.
• Coordinate with suppliers on CAPA, SCAR and supplier qualifications.
• Provide quality expertise in product development, design control, and risk management.
• Build device master records and assist with 510(k) submissions and CE files.
• Coordinate testing with internal/external labs and ensure regulatory compliance.
• Lead investigations of non-conformances and implement CAPA.
• Travel up to 15% as needed.

Education

Bachelor's degree in Engineering, Science, Math or related technical field

Job description

Medline Industries, LP is seeking a Quality Engineer- Anesthesia to join our healthcare quality team in Chicago. You will independently set basic quality standards for in-process work and lead efforts to test, sample, and train.

Responsibilities include designing experiments, applying SPC, performing product testing, and coordinating CAPA with suppliers while ensuring regulatory compliance (21 CFR 820, ISO13485).