Back to search
Quality Test Engineer
- Location: Â On-site in Danvers, MA
Â
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
Provide quality engineering support for process control of medical devices including product development, manufacturing operations, process verification and validation, conducting root cause analysis, auditing, calibration, testing and CAPA.Â
Key duties and responsibilities, other duties may be assigned:
- Serve as a liaison for providing quality engineering expertise for continuous process improvements for the engineering and manufacturing personnel
- Assist with initiatives in the quality department to meet goals and objectives and ensure compliance with regulations
- Test control software for complex electrical and mechanical equipment and be able to generate report with test results
- Perform incoming inspection on Mechanical, Electro-mechanical and Cable assemblies to a quality data plan using various inspection tools or test fixturing
- Represent Quality Assurance in Engineering Change Orders (ECO) and Material Review Boards (MRB) for manufacturing and supply chain.Â
- Review, coordinate and authorize disposition of nonconforming material
- Resolve quality issues providing technical input and guidance on process enhancements and improvements.Â
- Monitor & analyze production information to support risk management and lead corrective/preventative actions (CAPA)
- Review Device History Records for completeness
- Release or modify new or existing quality related procedures and provide training when needed
- Assist in supporting special projects for new products
- Coordinate calibration service needs for all test equipment
- Support the scheduling and installation efforts for products when being tested at the company’s registrar
- Promote teamwork and collaboration within the quality function and with other functional areas
- Perform other duties and functions as needed by Management
Education, Skills & Experience
- Bachelor’s in Engineering or related field preferred
- 5+ years of recent related experienceÂ
- Knowledge of Statistical Process Control, ISO 13485, FDA QSR
- Skills and expertise for creating, revising SOPs, and providing employee training.
- Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
- Must be excellent with technology, be able to present using a laptop computer, and be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint, as well as Outlook and Internet Explorer
Competencies
- High attention to detail
- Understanding of terminology and ability to share and communicate effectively within the group
- Ability to organize and prioritize tasks resulting in consistent productivity
- Ability to function within and support a team environment and build strong working relationships
- Dependable and punctual
- Ability to meet accuracy and productivity goals
- Good problem-solving skills, ability to evaluate situation and prioritize factors in decision making
- Self-motivated, utilize available resources for self-improvement and development
- Flexible: able to follow directives and accomplish tasks outside of normal dutiesÂ
Physical Requirements
- Regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move more than 80 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 timeÂ
- 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):Â 100% company paid
- Short/Long Term Disability, Life & AD&D (The Standard):Â 100% company paid
- 401k Retirement (Fidelity):Â 100% company match up to 5%
- Tax Deferred Health Care Savings Programs
- Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID TheftÂ
- Generous paid time off, tuition reimbursement, and more!
Inclusion and Diversity Statement:Â
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.
Learn more about this Employer on their Career Site
