Quality Engineer II

Company: NeuroLogica
Location: Danvers
Posted on: March 19, 2023

Job Description:

Quality Engineer IIWHO WE ARE: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 managing supplier audits and product safety testing standards in accordance with the requirements of the organization. Manage and administer QMS documentation system to ensure timely review, implementation, control with compliance to ISO, FDA, and other regulatory body standards.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Assist in maintaining and improving the quality management system documentation and processes to meet U.S. 21 CFR 820 (FDA QSR) and ISO 13485 requirements
• Support with initiatives in the quality department to meet goals and objectives and ensure compliance with regulations
• Execute verification needs on assemblies that have been internally repaired or reworked by the respective supplier
• Generate appropriate metrics to quantify supplier performance including maintaining analysis of failing components, subassemblies and other issues.
• Support the supplier evaluation process when selecting & qualifying new suppliers.
• Maintain the approved suppliers list, supplier scorecards and audit suppliers per schedule.
• Visiting supplier facilities and observing the manufacturing environment to review and assess their procedures
• Performing scheduled quality control audits to ensure vendors continue to work in compliance with company and FDA standards.
• Represent Quality Assurance in Material Review Boards (MRB) for manufacturing and supply chain.
• Originate nonconforming material reports for failed material requiring disposition
• Release or modify new or existing quality related procedures and provide training when needed
• Monitor & analyze production information to support risk management and lead corrective/preventative actions (CAPA)
• Provide Training and guidance to all departments on how to write and submit documentation
• Verify proper effectivity has been defined in the ECO process to make sure communication with appropriate departments
• Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer
• Perform other duties and functions as needed by Management
• Promote teamwork and collaboration within the quality function and with other functional areas
• Work independently with minimal supervision and as part of team
• Keep knowledge of all Samsung products up-to-dateEDUCATION & EXPERIENCE
  • Bachelor's Degree in engineering or Quality related field preferred.
  • 3+ years of related experience working with suppliers in manufacturing environment.
  • Ability to perform quality audits on suppliers to assure products and services meet ISO 13485
  • Preferred knowledge of environmental laws and regulations but not limited to global RoHS, REACH, WEEE, etc.
  • Excellent written, oral, and documentation skills
  • Knowledge of Statistical Process Control, ISO 13485, FDA QSR, MS Office (Excel and PowerPoint), Windows
  • Skills and expertise for creating and revising SOPs.
  • Ability to travel as needed
  • 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 hireCOMPUTER & 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 and Internet ExplorerPHYSICAL REQUIREMENTS
      • Occasionally lift and /or move up to 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 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 situationCOMPETENCIES
        • 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 dutiesAbout NeuroLogicaLocated 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;
          • 
            6 Different Blue Cross/Blue Shield Medical Plans to meet your needs
          • Dental coverage through Delta Dental
          • Vision coverage by VSP
          • 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!
            Please contact NeuroLogica if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment." Contact careers@neurologica.com for any questions or requests.
            NeuroLogica welcomes diversity and is an AA/EEO Employer - Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply. The company's AAP can be made available for inspections upon requests.

Keywords: NeuroLogica, Boston , Quality Engineer II, Professions , Danvers, Massachusetts