Senior Product Quality Engineer

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W2 Regular Full Time Danvers, MA, US

8 days ago Requisition

Salary Range: $ To $ Annually

Senior Product Quality Engineer

• Location:
  
  On-site in Danvers, MA

Who We Are

Samsung HME America (Healthcare and Medical Equipment) is Samsung’s U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung’s imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung’s mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide.

Backed by Samsung Electronics’ global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging.

The Sr. Product Quality Engineer is responsible for leading product quality, reliability, and compliance activities throughout the lifecycle of the Computed Tomography medical imaging systems. This role serves as the quality lead for sustaining products, manufacturing support, supplier quality, post-market surveillance, and continuous improvement initiatives.

The Sr. Product Quality Engineer partners closely with Engineering, Manufacturing, Service, Supply Chain, Regulatory Affairs, and Operations to ensure products consistently meet customer expectations, regulatory requirements, and business objectives.

This position drives complex investigations, risk assessments, corrective and preventive actions (CAPA), and product quality improvements while serving as a technical leader within the Quality organization. The role requires strong expertise in FDA-regulated medical device environments, root cause analysis, product reliability, and quality system compliance.

• Location:
  
  On-site in Danvers, MA

Samsung HME America (Healthcare and Medical Equipment) is Samsung’s U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung’s imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung’s mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide.

Backed by Samsung Electronics’ global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging.

The Sr. Product Quality Engineer is responsible for leading product quality, reliability, and compliance activities throughout the lifecycle of the Computed Tomography medical imaging systems. This role serves as the quality lead for sustaining products, manufacturing support, supplier quality, post-market surveillance, and continuous improvement initiatives.

The Sr. Product Quality Engineer partners closely with Engineering, Manufacturing, Service, Supply Chain, Regulatory Affairs, and Operations to ensure products consistently meet customer expectations, regulatory requirements, and business objectives.

This position drives complex investigations, risk assessments, corrective and preventive actions (CAPA), and product quality improvements while serving as a…