Quality Engineer II - Medical Devices (GMP, CAPA, SPC)

Nordson Corporation; Salem (NH); On-site; USD 85,000 - 110,000; Full time

Job summary

Nordson MEDICAL in Salem, NH is seeking a Quality Engineer II to ensure manufacturing operations meet GMP, FDA quality standards and ISO 13485. You will participate in root-cause analysis, CAPA, and process validation activities to ensure product quality.

You will lead gauge R&R studies, support QA documents (SOPs, MAPs, QAPs), drive cost reductions and scrap reduction, and act as Quality representative for MRB and SCAR processes, collaborating with cross-functional teams.

Qualifications

• Experience with quality systems and GMP/FDA standards.
• Ability to participate in multidisciplinary teams for root-cause analysis and corrective actions.
• Experience designing, executing, and documenting gauge R&R studies.

Responsibilities

• Participate in multidisciplinary teams to implement root-cause analysis, CAPA, and validation of effectiveness.
• Design, execute and document gauge 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 and scrap.
• Act as Quality Representative for MRB; manage SCAR processes and supplier communications.
• Investigate and respond to customer complaints and SCARs; support Process and Transfer Validations.

Skills

Root-cause analysis

CAPA investigations

Gauge R&R

SPC

Tools

SPC

Job description

Nordson MEDICAL in Salem, NH is seeking a Quality Engineer II to ensure manufacturing operations meet GMP, FDA quality standards and ISO 13485. You will participate in root-cause analysis, CAPA, and process validation activities to ensure product quality.

You will lead gauge R&R studies, support QA documents (SOPs, MAPs, QAPs), drive cost reductions and scrap reduction, and act as Quality representative for MRB and SCAR processes, collaborating with cross-functional teams.