Senior Product Quality Engineer

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.

Role Description

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.

Key duties and responsibilities, other duties may be assigned:

Product Quality Ownership

• Serve as the Product Quality Engineering lead for assigned product families throughout the product lifecycle.
• Monitor and analyze quality performance metrics, manufacturing yield data, complaint trends, service data, and field reliability indicators.
• Establish and maintain product quality dashboards and KPI reporting.
• Drive continuous improvement initiatives to improve product quality, reliability, manufacturability, and customer satisfaction.
• Act as the primary quality representative for cross-functional product teams.

Investigation and Problem Solving

• Lead investigations of product failures, nonconformances, customer complaints, and field-returned devices.
• Perform data-driven root cause analyses using quality tools including:
  • 5 Whys
  • Pareto Analysis
  • Fishbone Analysis
  • Statistical Analysis
  • Fault Tree Analysis
  • Failure Mode and Effects Analysis (FMEA)
• Identify systemic quality issues and implement sustainable corrective actions.
• Present investigation findings and recommendations to management and cross-functional teams.

CAPA and Risk Management

• Lead CAPA activities from initiation through effectiveness verification and closure.
• Ensure timely investigation, documentation, and resolution of quality issues.
• Drive preventive actions that reduce recurrence and improve product robustness.
• Support management review activities through quality trend analysis and risk reporting.

Manufacturing and Sustaining Quality Support

• Serve as the primary quality partner for manufacturing operations and sustaining engineering teams.
• Support manufacturing process improvements to reduce defects, improve yields, and enhance product reliability.
• Evaluate production processes, inspection methods, and test strategies.
• Support process validations, equipment qualifications, software validations, and verification activities.
• Develop, review and approve manufacturing quality documentation, procedures, and work instructions.

Design Change and Product Lifecycle Management

• Represent Quality Engineering in design reviews, Engineering Change Orders (ECOs), and product change activities.
• Review and approve quality-related deliverables associated with product modifications
• Support new product introduction (NPI), design transfer, and commercialization activities.
• Ensure quality and regulatory requirements are incorporated into product and process changes.
• Collaborate with Engineering teams to evaluate product risk and quality impact of design changes.

Post-Market Surveillance and Field Quality

• Lead complaint evaluations, field investigations, and post-market surveillance activities.
• Analyze service data, complaint trends, and field performance information to identify emerging quality issues.
• Participate in Medical Device Reporting (MDR) assessments and regulatory reporting activities as required.
• Lead failure analysis activities for returned products and components.
• Recommend and implement improvements based on field performance data.

Qualifications and Requirements:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education, Skills & Experience

• B.S. in Engineering required. Mechanical, Electrical or Mechatronics Engineering degree preferred.
• 10+ years of experience in manufacturing or service of electro-mechanical or other complex systems
• Proven problem solver & clear thinker. Skilled in leading quality investigations and quality improvement projects to deliver exceptional results within a predictable timeline.
• Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors and customers.
• Flexible: able to follow directives and accomplish tasks outside of normal duties
• Proficiency with MS Office Suite (Excel, Word, PowerPoint, Outlook, etc.) and Minitab
• Knowledge of Medical Device Regulatory & Quality Standards in the following is preferred:

• • ISO 13485 / MDSAP / EU MDR
  • IEC 60601-1 standards for Medical Devices safety, EMC and usability requirements
  • ISO 14971 Risk Management requirements
• Strong technical understanding of imaging system performance testing and regulatory compliance

Physical Requirements

• Occasionally lift and /or move up to 25 pounds
• Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear
• Must be able to sit for long periods of time
• The noise level in the work environment is usually mild.
• Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus
• Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation

Benefits

We offer a comprehensive benefit package which includes:

• Medical (Blue Benefit Administrators): 5 PPO Plans (with up to 95% employer contribution)
• Dental (Blue Cross Blue Shield): 2 PPO Plans (with up to 80% employer contribution)
• Vision (Blue Cross Blue Shield): 100% company paid
• Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
• 401k Retirement (Fidelity): 100% company match up to 5%
• Tax Deferred Health Care Savings Programs
• Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft
• Generous paid time off, tuition reimbursement, and more!

Inclusion and Diversity Statement: We are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We are committed to providing reasonable accommodation to individuals with disabilities throughout the application and employment process. If you require assistance or accommodation, please contact Human Resources.