Quality Engineer, Medical Devices – CAPA & SPC

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries in Chicago is seeking a quality-focused professional to independently set basic quality standards for in-process controls and to lead development of testing, sampling, and training methods. You will evaluate production processes, propose improvements, and manage DMRs, product specs, and design control files to support CE and regulatory submissions.

The role involves vendor management, CAPA, SCAR, and collaboration with Regulatory groups while ensuring compliance with 21 CFR

Qualifications

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

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, improvement, testing and inspection.
• Design experiments to understand sources of variation and apply SPC to analyze data.

Job description

Medline Industries in Chicago is seeking a quality-focused professional to independently set basic quality standards for in-process controls and to lead development of testing, sampling, and training methods. You will evaluate production processes, propose improvements, and manage DMRs, product specs, and design control files to support CE and regulatory submissions.

The role involves vendor management, CAPA, SCAR, and collaboration with Regulatory groups while ensuring compliance with 21 CFR