Senior Medical Imaging Quality Engineer

NeuroLogica Corp.; Danvers (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Samsung HME America in Danvers, MA is seeking a Senior Product Quality Engineer to lead quality, reliability, and regulatory compliance for CT imaging systems. This on-site role partners with Engineering, Manufacturing, Service, and Regulatory Affairs to ensure products meet customer expectations and FDA requirements throughout the lifecycle.

The successful candidate will drive CAPA, risk management, investigations, and quality improvements, with strong expertise in FDA-regulated environments

Qualifications

• B.S. in Engineering required (Mechanical, Electrical or Mechatronics preferred).
• 10+ years in manufacturing or service of electro-mechanical or complex systems.

Responsibilities

• Lead product quality ownership across product lifecycle.
• Drive investigations of failures and nonconformances.
• Lead CAPA activities and risk management.
• Support manufacturing and sustaining quality improvements.
• Collaborate with Engineering and Regulatory teams on design changes.

Skills

Problem solving

Quality investigations

Regulatory knowledge

MS Office

Minitab

Education

B.S. in Engineering

Tools

MS Office

Minitab

Job description

Samsung HME America in Danvers, MA is seeking a Senior Product Quality Engineer to lead quality, reliability, and regulatory compliance for CT imaging systems. This on-site role partners with Engineering, Manufacturing, Service, and Regulatory Affairs to ensure products meet customer expectations and FDA requirements throughout the lifecycle.

The successful candidate will drive CAPA, risk management, investigations, and quality improvements, with strong expertise in FDA-regulated environments