Quality Engineer — SPC, CAPA & Medical Device QA

Medline Industries, LP; Norristown (Montgomery County); 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 seeks a Quality/Engineering professional to develop and implement methods for process control, validation, testing, and inspection. You will design experiments, apply SPC, and lead supplier qualifications to ensure compliant, high-quality products.

The role involves collaborating with Regulatory Groups, creating 510(k) submissions, and maintaining design control documentation. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in engineering, science, math or related field.
• At least 2 years of experience in quality or engineering.
• Experience with MS Office, especially Excel (intermediate).

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, improvement, testing and inspection to ensure products are ideal and functional.
• Design experiments to understand sources of variation affecting products and processes.
• Apply SPC methods for data analysis to evaluate the current process and changes.
• Design and perform experimental product testing and analysis to maintain quality and minimize defects.
• Generate and analyze reports and defective products to identify trends and drive CAPA actions.
• Lead supplier qualifications and collaborate with suppliers on quality issues.

Skills

Time management

Problem solving

Independence

Communication

Education

Bachelor’s degree in engineering/science/math

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries, LP seeks a Quality/Engineering professional to develop and implement methods for process control, validation, testing, and inspection. You will design experiments, apply SPC, and lead supplier qualifications to ensure compliant, high-quality products.

The role involves collaborating with Regulatory Groups, creating 510(k) submissions, and maintaining design control documentation. Travel up to 15% may be required.