Quality Engineer: Medical Devices Process & CAPA Expert

Medline; Northfield Township (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a quality professional to set basic in-process quality standards and lead method development for testing, sampling and training. Responsibilities include evaluating production processes, recommending improvements, vendor management, and maintaining DMRs and CE technical files.

Additional duties cover process control design, SPC analysis, design of experiments, CAPA with suppliers, and supporting design control, risk management and compliance with 21 CFR 820 and

Qualifications

• Bachelor's degree in Engineering, Science, Math or other related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience with 21 CFR 820 and ISO13485 or similar standards; proficient with MS Office.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing, and inspection.
• Design experiments to study variation and apply SPC methods.
• Perform product testing and analysis to maintain quality and reduce defects.
• Lead supplier quality activities and CAPA/SCAR, and supplier qualifications.
• Contribute to Design Control, Risk Management, and CE Technical Files; prepare Device Master Records.
• Coordinate design documentation reviews for compliance with requirements.

Skills

Time management

Problem solving

MS Office

Excel

Regulatory knowledge

Education

Bachelor's degree

Tools

Regulatory standards

Job description

Medline Industries, LP is seeking a quality professional to set basic in-process quality standards and lead method development for testing, sampling and training. Responsibilities include evaluating production processes, recommending improvements, vendor management, and maintaining DMRs and CE technical files.

Additional duties cover process control design, SPC analysis, design of experiments, CAPA with suppliers, and supporting design control, risk management and compliance with 21 CFR 820 and