Senior Product Quality Engineer

Samsung HME America Inc • Danvers, MA

1d • Onsite

About The Position

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.

Requirements

• 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
• Strong technical understanding of imaging system performance testing and regulatory compliance

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior