Senior Quality Engineer - Medical Devices & CAPA Expert

Medline; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Medline Industries, LP is seeking a Quality Engineer to independently set basic quality standards for in-process and develop testing methods, sampling, and training. You will evaluate production processes, qualify vendors, and generate DMRs and CE files to ensure compliance.

The role requires experience with quality systems, 21 CFR 820, ISO13485, and the ability to perform SPC, CAPA, and risk management. Up to 15% travel may be required.

Qualifications

• Bachelor's degree in engineering, science, math or related technical field.
• Minimum 4 years of experience in quality or engineering and knowledge of government/industry quality assurance codes.
• Familiarity with 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.

Responsibilities

• Develop and implement methods for process control, validation, testing, and inspection to ensure product functionality.
• Design experiments and apply SPC to analyze data and assess process changes.
• Lead investigations of non-conformances and drive CAPA actions.
• Coordinate with suppliers on quality issues and lead supplier qualifications.
• Develop device master records and design control files, and prepare CE technical files as required.

Skills

Quality engineering

SPC

Project management

MS Office

Advanced Excel

Team leadership

Data analysis

Travel up to 15%

Education

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

Tools

MS Word

MS Excel

MS PowerPoint

MS Outlook

Job description

Medline Industries, LP is seeking a Quality Engineer to independently set basic quality standards for in-process and develop testing methods, sampling, and training. You will evaluate production processes, qualify vendors, and generate DMRs and CE files to ensure compliance.

The role requires experience with quality systems, 21 CFR 820, ISO13485, and the ability to perform SPC, CAPA, and risk management. Up to 15% travel may be required.