Quality Engineer II CAPA & Process Improvement

Nordson; Salem (AL); On-site; USD 85,000 - 120,000; Full time

Job summary

Nordson MEDICAL is seeking an experienced quality professional to join our team in the United States. The role focuses on ensuring compliance with GMP, ISO 13485, and FDA standards while leading root-cause investigations, CAPA activities, and quality system improvements across manufacturing operations.

You will design and document gage R&R studies, support SOP training, and drive cost reductions through COPQ initiatives.

Qualifications

• Bachelor's degree in engineering or related discipline; may substitute for experience.
• Minimum of 5 years related experience in medical device industry.
• Knowledge of ISO 13485:2003, GMP, FDA, QSR.
• Strong root-cause investigation and problem-solving in manufacturing.
• Mechanical aptitude with manufacturing experience.

Responsibilities

• Ensure manufacturing operations follow GMP, GDP, ISO 13485 and FDA standards.
• Lead root-cause analysis, CAPA and corrective actions.
• Design, execute and document gage R&R studies.
• Support training on SOPs and QA documents (SOPs, PIs, MAPs, QAPs).
• Lead process improvement events to reduce COPQ.
• Reduce scrap and manufacturing waste across product lines.
• Quality Representative for MRB and SCAR processes.
• Investigate customer complaints and supplier SCARs.
• Prepare quality deliverables and engineering studies as needed.
• Implement SPC and lean QMS initiatives.
• Eliminate all escapes to the customer; target zero.

Skills

Root-cause analysis

Problem solving

Manufacturing experience

Quality system knowledge

Education

Bachelor's degree in engineering or related discipline

Job description

Nordson MEDICAL is seeking an experienced quality professional to join our team in the United States. The role focuses on ensuring compliance with GMP, ISO 13485, and FDA standards while leading root-cause investigations, CAPA activities, and quality system improvements across manufacturing operations.

You will design and document gage R&R studies, support SOP training, and drive cost reductions through COPQ initiatives.