Senior Quality Engineer, Medical Devices & CAPA

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, Inc. seeks a quality professional who will independently set basic quality standards for in-process work and lead development of testing, sampling and training methods.

You will evaluate production processes, qualify vendors, and generate master records, product specifications, design controls and CE technical files to ensure regulatory compliance. Major responsibilities include designing experiments and applying SPC, conducting product testing and analysis, leading CAPA with

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of Quality or Engineering experience.
• Knowledge of QA codes and standards (21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO sterilization).

Responsibilities

• Manage development and implementation of methods for process control, validation, improvement, testing and inspection.
• Design experiments using SPC to understand variation and guide process changes.
• Perform product testing and analysis to maintain quality and reduce defects.
• Lead supplier quality activities including CAPA, SCAR and supplier qualifications.
• Provide quality input in Product Development, Design Controls and CE technical files; coordinate 510K submissions when required.
• Coordinate product testing with internal and external labs and ensure regulatory compliance.
• Lead investigations of non-conformances and drive CAPA.
• May train teammates on processes and best practices; act as Quality lead when needed.

Skills

Quality leadership

Problem solving

Time management

Cross-functional collaboration

MS Office

Advanced Excel

Travel readiness

Education

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

Job description

Medline Industries, Inc. seeks a quality professional who will independently set basic quality standards for in-process work and lead development of testing, sampling and training methods.

You will evaluate production processes, qualify vendors, and generate master records, product specifications, design controls and CE technical files to ensure regulatory compliance. Major responsibilities include designing experiments and applying SPC, conducting product testing and analysis, leading CAPA with