Quality Engineer II: CAPA, Process Improvement & GMP

Nordson Corporation; New Hampshire; On-site; USD 70,000 - 95,000; Full time

Job summary

Nordson Medical is seeking a quality-focused professional to join our team in the United States. You will help ensure that manufacturing operations comply with GMP, GDP, ISO 13485, and 21 CFR Part 820 while supporting root-cause analysis, CAPA, and quality improvements.

You will participate in cross-functional teams, lead process improvement efforts, and drive reduction of scrap and COPQ. The role involves documenting tests, validating processes, and ensuring timely quality deliverables across

Responsibilities

• Participate in multidisciplinary teams to implement root-cause analysis and CAPA.
• Design, execute and document gage R&R studies.
• Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs).
• Lead process improvement events to reduce cost of poor quality (COPQ).
• Reduce scrap and manufacturing waste across product lines.
• Quality Representative for Material Review Board (NMR) for components.
• Conduct and follow up of SCAR process (SCAR issuance, supplier notification, SCAR approval).
• Investigate and respond to customer complaints and SCARs.
• Quality Representative for Process Validations and Transfer Validations.
• Prepare quality related deliverables and engineering studies.
• Responsible for CAPA root cause investigation and actions implementation.
• Implementation of SPC.
• Eliminate all escapes to the customer.
• Creates Controls plans and meet KPI goals.

Job description

Nordson Medical is seeking a quality-focused professional to join our team in the United States. You will help ensure that manufacturing operations comply with GMP, GDP, ISO 13485, and 21 CFR Part 820 while supporting root-cause analysis, CAPA, and quality improvements.

You will participate in cross-functional teams, lead process improvement efforts, and drive reduction of scrap and COPQ. The role involves documenting tests, validating processes, and ensuring timely quality deliverables across