NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography, and is also the US headquarters for sales, marketing, service and distribution of all Samsung digital radiography and ultrasound systems. Our advanced medical technologies are used worldwide in leading healthcare institutions, helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. Samsung is committed to being a leader in the field of healthcare imaging.
Samsung is a growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. In 2015, NeuroLogica became the US headquarters for all of Samsung Health and Medical Equipment. The full range of Samsung imaging solutions includes Ultrasound, Digital Radiography, and mobile Computed Tomography (mCT). Samsung aims to become a global leader in the medical imaging space and is investing heavily in developing innovative, advanced imaging technologies that will improve the quality of people's lives.
Samsung keeps a constant eye on the always-evolving, ever-changing imaging industry. By continually enhancing current product lines and seeking to develop new technologies, Samsung is at the forefront of the imaging frontier.
ROLE DESCRIPTION:
Responsible for inspection, testing and process improvement to ensure high quality computed tomography medical imaging products and compliance with regulatory standards and guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned
Manage daily QC operations including in process checks during manufacturing and final release of imaging systems
Responsible for QC testing including (system and software) verification and validation for design changes and manufacturing improvement
Investigate and document nonconformances, deviations, and product defects; lead root cause analysis and corrective actions
Define, maintain, and improve QC documentation and processes to meet U.S. FDA 21 CFR 820 (FDA QMSR), MDSAP, EU MDR, ISO 14971 and ISO 13485 requirements
Testing for sub-assemblies and system level testing for finished products
External safety testing for changes at system level, critical components and end of life parts
Generate appropriate metrics to quantify product quality including maintaining analysis of failing components, subassemblies and other issues.
Facilitate failure analysis and field defect analysis along with trending information
Serves as a liaison for providing quality engineering expertise for continuous process improvements for the engineering, service and manufacturing personnel
Review and verify product labeling
Work with and respond to, inquiries from regulatory agencies and assist with audits and inspections
Contribute directly or manage designee to product ship reviews
Direct the Incoming Inspection process of first articles, populated board assemblies and cable assemblies
Provide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements and industry practices
Assist with initiatives in the quality department to order to meet corporate goals and objectives and ensure compliance with medical device regulations
Perform other duties and functions as needed by Management
Assist with preparing field action documentation and executing the field action process
Promote teamwork and collaboration within the quality function and with other functional areas
Facilitate risk management activities (RMF, Risk/Benefit, planning, etc.) as deemed needed for all products to ensure compliance with regulating bodies
Ability to create updates for Management Review Meeting
Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors and the customer as required
EDUCATION & EXPERIENCE
Bachelor’s in Engineering, Quality or related field preferred
7+ years of related experience in the Quality Control / Quality Assurance, with 3+ years in a leadership role in the medical device or imaging industry.
Strong knowledge of ISO 13485 / MDSAP / EU MDR
Strong technical understanding of imaging system performance testing and regulatory compliance
Familiarity with IEC 60601-1 standards for Medical Devices safety, EMC and usability requirements
Expertise in the use of Risk Management requirements via ISO 14971
Ability to communicate effectively with engineers, assemblers, and management through all media
Skills and expertise for creating, revising SOPs and providing employee training.
Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
Excellent written, oral, and documentation skills
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire
COMPUTER & ANALYTIC SKILLS
Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment
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
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
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 duties
About NeuroLogica
Located North of Boston in Danvers, MA, NeuroLogica Corporation, a subsidiary of Samsung Electronics, develops, manufactures and markets innovative medical imaging equipment for healthcare facilities and private practices worldwide. As a fast-moving, entrepreneurial company, NeuroLogica is a rapidly growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. We welcome you to learn more at: https://www.neurologica.com .
We offer a comprehensive benefit package which includes;
- 4 Different Blue Cross/Blue Shield Medical Plans to meet your needs
- Dental coverage through BlueCross/Blue Shield Dental
- Vision coverage by Blue Cross/Blue Shield
- Company paid Short-term and Long-term Disability coverage
- $1 for $1 401k match up to 5% managed by Fidelity
- Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more!
NeuroLogica welcomes diversity and is an AA/EEO Employer – Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply.
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