Quality Engineer - Medical Devices, Process & CAPA Lead

Medline Industries, Inc.; Howell Township (NJ); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Howell Township, NJ seeks a qualified professional to set basic in-process quality standards and lead methods for testing, sampling and training. You will evaluate production processes, design validation, and manage DMRs, design control files, and CE technical files.

The role emphasizes applying SPC, performing product testing analyses, and driving corrective actions with suppliers. Travel up to 15% may be required in this medical devices context.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• 2+ years of experience in Quality or Engineering.
• Experience applying statistical quality control and problem solving.

Responsibilities

• Set basic quality standards for in-process and lead testing, sampling and training efforts.
• Develop methods and procedures for process control, validation, improvement, testing and inspection.
• Review design documentation for compliance with requirements and coordinate testing with laboratories.
• Lead CAPA investigations and supplier quality improvements; manage 510K submissions and CE files when required.
• Ensure compliance with 21 CFR 820, ISO 13485 and related regulations.

Tools

MS Office Suite

Job description

Medline Industries, LP in Howell Township, NJ seeks a qualified professional to set basic in-process quality standards and lead methods for testing, sampling and training. You will evaluate production processes, design validation, and manage DMRs, design control files, and CE technical files.

The role emphasizes applying SPC, performing product testing analyses, and driving corrective actions with suppliers. Travel up to 15% may be required in this medical devices context.