Senior Quality Engineer, Medical Imaging Systems Leader

Samsung Healthcare USA; Danvers (MA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

401k with employer match

Paid time off

Job summary

Samsung HME America is seeking a Sr. Product Quality Engineer to lead quality, reliability, and compliance for its Computed Tomography imaging systems.

You will partner with Engineering, Manufacturing, Service, Supply Chain, Regulatory Affairs, and Operations to ensure regulatory compliance and customer satisfaction. The role requires strong expertise in FDA-regulated medical devices, root-cause analysis, and quality system compliance, with a focus on sustaining products and continuous

Qualifications

• B.S. in Engineering required. Mechanical, Electrical or Mechatronics preferred.
• 10+ years of experience in manufacturing or service of electro-mechanical or other complex systems.
• Proven problem solver and clear thinker; skilled in leading quality investigations and improvement projects.

Responsibilities

• Lead product quality ownership for assigned product families across lifecycle.
• Coordinate investigations of product failures, nonconformances, and customer complaints; perform data-driven analyses.
• Lead CAPA activities and risk management; drive preventive actions and management reviews.

Skills

Problem solving

Root cause analysis

Data analysis

Communication

Education

B.S. in Engineering

Tools

MS Office

Minitab

Job description

Samsung HME America is seeking a Sr. Product Quality Engineer to lead quality, reliability, and compliance for its Computed Tomography imaging systems.

You will partner with Engineering, Manufacturing, Service, Supply Chain, Regulatory Affairs, and Operations to ensure regulatory compliance and customer satisfaction. The role requires strong expertise in FDA-regulated medical devices, root-cause analysis, and quality system compliance, with a focus on sustaining products and continuous