Quality Engineer II: Drive Zero Escapes, Process Excellence

Nordson MEDICAL (NH), Inc.; Salem (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

Nordson MEDICAL is seeking an experienced quality-focused professional to ensure manufacturing operations comply with GMP, GDP, ISO 13485, and 21 CFR Part 820. The role involves leading CAPA, SCARs, and CPQ reduction efforts across multiple product lines, plus driving validations, quality documentation, and process improvements.

You will participate in cross-functional teams, conduct gage R&R studies, support SOP trainings, and act as a quality consultant across the organization to prevent

Qualifications

• Assure manufacturing operations follow GMP/GDP and ISO 13485 standards.

Responsibilities

• Participate in multidisciplinary teams to implement root-cause analysis and CAPA actions.
• Design, execute and document gage R&R studies.
• Support training on SOPs, PIs, MAPs, and QAPs.
• Lead process improvement events to reduce COPQ and waste.
• Represent quality in Material Review Board (NMR) for components.
• Manage SCAR processes including supplier notification and effectiveness review.
• Investigate customer complaints and customer-issued SCARs.
• Lead or support validations (Process Validations, Transfer Validations).
• Prepare quality deliverables and engineering studies as needed.
• Assist in CAPA root cause investigations and corrective actions.
• Implement SPC and Lean QMS initiatives.

Skills

Root cause analysis

CAPA

Gage R&R

Process validation

SPC

SOP training

Quality systems

SCAR management

Lean QMS

Internal audits

Regulatory compliance

Job description

Nordson MEDICAL is seeking an experienced quality-focused professional to ensure manufacturing operations comply with GMP, GDP, ISO 13485, and 21 CFR Part 820. The role involves leading CAPA, SCARs, and CPQ reduction efforts across multiple product lines, plus driving validations, quality documentation, and process improvements.

You will participate in cross-functional teams, conduct gage R&R studies, support SOP trainings, and act as a quality consultant across the organization to prevent