Quality Engineer – Medical Devices, SPC & CAPA

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

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Engineer for Dynacor Kitting (Maintenance). You will independently set basic quality standards for in-process activities and help develop testing, sampling, and training methods.

Responsibilities include assessing production processes, driving improvements, managing vendor CAPA/SCAR, maintaining DMRs and CE/510K artifacts, and collaborating with suppliers and regulatory groups to ensure compliance.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• At least 2 years in Quality or Engineering.
• Experience with SPC and process validation.
• Knowledge of 21 CFR 820 or ISO 13485 is a plus.
• Ability to travel up to 15%.

Responsibilities

• Manage development and implementation of methods for process control, validation, improvement, testing, and inspection.
• Design experiments to understand variation; apply SPC methods for data analysis.
• Perform experimental product testing and analysis; generate reports and CAPA actions.
• Collaborate with supplier representatives on quality issues; lead supplier qualifications.
• Provide Quality expertise in Product Development and Design Control activities.
• Prepare documentation (Device Master Records) and 510K submissions with Regulatory Groups.
• Coordinate product testing with internal and external laboratories.
• Ensure compliance with domestic and international regulations; conduct design reviews.
• Lead investigations of non-conformances and develop CAPAs.

Skills

Self-management

Time management

Problem solving

MS Office Suite

Excel proficiency

Quality standards knowledge

Education

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

Tools

MS Office Suite

Job description

Medline Industries, LP is seeking a Quality Engineer for Dynacor Kitting (Maintenance). You will independently set basic quality standards for in-process activities and help develop testing, sampling, and training methods.

Responsibilities include assessing production processes, driving improvements, managing vendor CAPA/SCAR, maintaining DMRs and CE/510K artifacts, and collaborating with suppliers and regulatory groups to ensure compliance.