Senior Medical Device Quality Engineer (SPC & CAPA)

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

Job summary

Medline Industries, LP is seeking a quality leading professional to independently establish basic quality standards for in-process and testing activities. You will drive methods for testing, sampling, and training, evaluate production processes, and manage DMRs, product specs, and CE/510(k) related files with Regulatory.

This role requires overseeing CAPA, SCAR, supplier qualifications, and design control activities to assure compliance and quality across product lines.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• Typical minimum four years of experience in Quality or Engineering.
• Experience with government and industry quality standards (e.g., 21 CFR 820, ISO13485).
• Ability to work with little supervision and manage multiple deadlines.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments and apply SPC to analyse variation in products and processes.
• Perform product testing and analyses to maintain quality and reduce defects.
• Lead supplier quality activities and CAPA/SCAR actions with suppliers.
• Prepare device master records and 510(k) documentation with Regulatory groups.
• Ensure compliance with domestic and international regulations.
• Lead investigations and corrective actions for non-conformances.
• Train Medline staff on processes and best practices.

Skills

Excel advanced

MS Office

Statistical analysis

Process improvement

CAPA

Quality assurance

Vendor management

Project leadership

Cross-functional teamwork

Education

Bachelor’s degree in Engineering/Science

Tools

MS Office Suite

Job description

Medline Industries, LP is seeking a quality leading professional to independently establish basic quality standards for in-process and testing activities. You will drive methods for testing, sampling, and training, evaluate production processes, and manage DMRs, product specs, and CE/510(k) related files with Regulatory.

This role requires overseeing CAPA, SCAR, supplier qualifications, and design control activities to assure compliance and quality across product lines.