Quality Engineer II - Medical Devices, Process Improvement

Nordson Corporation; Salem (VA); On-site; USD 70,000 - 100,000; Full time

Job summary

Nordson Medical is seeking a quality-focused engineer to ensure GMP, ISO 13485, and 21 CFR 820 compliance across manufacturing operations. You will drive CAPA, lead root-cause analyses, and support process validation and transfer activities.

Join a global team to reduce scrap and COPQ, develop SPC controls, and mentor teams on QMS documents and SOPs. This role emphasizes quality culture and continuous improvement.

Qualifications

• Experience implementing quality systems in medical device manufacturing.
• Proven ability to lead CAPA investigations and actions.
• Strong knowledge of GMP, ISO 13485, and 21 CFR Part 820.

Responsibilities

• Participate in multidisciplinary teams for root-cause analysis and CAPA.
• Design, conduct, and document gage R&R studies.
• Support training on SOPs, PIs, MAPs, QAPs.

Skills

Quality Systems

CAPA

Root Cause

Gage R&R

SPC

GMP

ISO 13485

21 CFR 820

Job description

Nordson Medical is seeking a quality-focused engineer to ensure GMP, ISO 13485, and 21 CFR 820 compliance across manufacturing operations. You will drive CAPA, lead root-cause analyses, and support process validation and transfer activities.

Join a global team to reduce scrap and COPQ, develop SPC controls, and mentor teams on QMS documents and SOPs. This role emphasizes quality culture and continuous improvement.