Quality Engineer – Process Control & CAPA

Regulatory Jobs; Norristown (Montgomery County); On-site; USD 79,000 - 119,000; Full time

Job summary

Medline Industries, LP is seeking a Quality Engineer to set basic quality standards, develop testing methods, and oversee vendor qualification to ensure compliant medical devices.

Under broad supervision, you will design experiments, apply SPC, perform CAPA, manage design controls, and prepare DMRs, product specs, and CE technical files.

This position involves domestic travel up to 15% and offers benefits, salary range $79,000 to $119,000 annually.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience developing ways of accomplishing goals with minimal supervision.
• Experience using time management to manage multiple projects.
• Experience problem solving and applying statistical methods.
• Working knowledge of MS Office (Word, Excel, PowerPoint, Outlook).
• Knowledge of quality codes and standards (e.g. 21 CFR 820, ISO13485).
• Willingness to travel up to 15%.

Responsibilities

• Develop and implement methods and procedures for process control, validation, testing and inspection.
• Design experiments to understand variation, apply SPC to evaluate processes.
• Lead supplier qualifications, CAPA, and SCAR activities.
• Provide quality expertise in product development, design controls and CE technical files.
• Coordinate testing with internal and external labs; prepare DMRs and product specifications.
• Ensure compliance with domestic and international regulations; review design documentation.
• Lead investigations of non-conformances and implement corrective actions.

Skills

Quality engineering

SPC

CAPA

Vendor management

MS Office

Excel (advanced)

Regulatory knowledge (FDA 21 CFR 820,

Travel willingness

Education

Bachelor's degree in Engineering/Science/Math or related field

Tools

MS Office Suite

Job description

Medline Industries, LP is seeking a Quality Engineer to set basic quality standards, develop testing methods, and oversee vendor qualification to ensure compliant medical devices.

Under broad supervision, you will design experiments, apply SPC, perform CAPA, manage design controls, and prepare DMRs, product specs, and CE technical files.

This position involves domestic travel up to 15% and offers benefits, salary range $79,000 to $119,000 annually.