Quality Engineer – Medical Devices, Process & CAPA

Medline; 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 seeks a quality-focused professional to set basic quality standards for in-process testing and to lead development of methods for testing, sampling and training. You will evaluate production processes, qualify vendors, and maintain DMRs, product specifications, and CE technical files.

You will design experiments using SPC, perform product testing, and lead CAPA investigations. Collaboration with Regulatory and Suppliers to produce 510(k) submissions is required.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• 2+ years of experience in Quality or Engineering.
• Experience in Medical Devices, Drugs, or related fields.
• Experience using MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Intermediate Microsoft Excel skills (conditional formatting, tables, formulas, charts).
• Knowledge of government/industry QA codes and standards (21 CFR 820, ISO13485).
• Travel up to 15%.

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, testing, and inspection to ensure products are ideal and functional.
• Design experiments using SPC to understand variation and evaluate processes.
• Perform product testing and analysis to maintain quality, minimize defects, and drive CAPA.
• Collaborate with suppliers on quality problems and lead supplier qualification programs.
• Provide QA expertise in Product Development, Design Control, Risk Management, and CE Technical Files.
• Prepare device master records and collaborate with Regulatory for 510(k) submissions and letters to file.

Skills

Time management

Problem solving

MS Office Suite

Excel advanced

QA standards

Education

Bachelor’s degree in Engineering/Science/Math

Tools

MS Office Suite

Job description

Medline Industries, LP seeks a quality-focused professional to set basic quality standards for in-process testing and to lead development of methods for testing, sampling and training. You will evaluate production processes, qualify vendors, and maintain DMRs, product specifications, and CE technical files.

You will design experiments using SPC, perform product testing, and lead CAPA investigations. Collaboration with Regulatory and Suppliers to produce 510(k) submissions is required.