On-site Quality Engineer: Drive Process Excellence & CAPA

Medline; Norristown (Montgomery County); Hybrid; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline in Norristown, PA is seeking a Quality Engineer to set basic quality standards for in-process activities and lead testing, sampling and training development. You will evaluate production processes, qualify suppliers, and maintain DMRs, design control files and CE technical files.

Responsibilities include designing experiments, applying SPC, performing product testing, and leading CAPA/SCAR programs. Travel up to 15% and compliance with 21 CFR 820/ISO13485 are required.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience solving problems, meeting deadlines and working with minimal supervision.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments to understand variation and apply SPC to evaluate processes.
• Lead supplier qualifications and CAPA/SCAR programs; collaborate with suppliers to drive corrective actions.
• Build and maintain product documentation (Device Master Records) in compliance with regulations.
• Coordinate testing with internal and external labs and support CE/510(k) activities.
• Investigate non-conformances and drive corrective and preventive actions.

Skills

MS Excel

Time management

Problem solving

MS Office Suite

Education

Bachelor’s degree in Engineering/Science/Math

Tools

MS Office Suite

Job description

Medline in Norristown, PA is seeking a Quality Engineer to set basic quality standards for in-process activities and lead testing, sampling and training development. You will evaluate production processes, qualify suppliers, and maintain DMRs, design control files and CE technical files.

Responsibilities include designing experiments, applying SPC, performing product testing, and leading CAPA/SCAR programs. Travel up to 15% and compliance with 21 CFR 820/ISO13485 are required.