Topcon

  • Quality Assurance Administrator

    Requisition ID
    2018-2807
    Experience Level
    Specialist
    Industry
    Medical
    Employment Status
    Regular Full-Time
    Location : Location
    US-NJ-Oakland
    Category
    Quality Control
  • Overview

    Topcon is a comprehensive ophthalmic device manufacturer within the worldwide ophthalmic community. It introduced the world’s first commercial back-of-the-eye spectral domain (SD) and swept source (SS) optical coherence tomography (OCT) systems, which have driven innovation in eye-care.

    More recently, Topcon Healthcare Solutions started to enhance not only its hardware but also its software solutions. To become the leader in diagnostic software, Topcon has developed a new strategic division whose primary objective is to create world-class software solutions for the eye-care industry and beyond. Our products enable the collection and visualization of a wide range of imaging and clinical data while providing quantitative and clinical analysis capabilities. Topcon’s software gives clinicians access to patient exam data captured from OCTs, Visual Fields, Fundus cameras, and other Topcon and third-party devices. We leverage Topcon’s image management software called Synergy, where practitioners gain access to DICOM and non-DICOM information stored in a central, cloud-based environment. Additionally, Topcon now provides an integrated service that connects practitioners to an extensive network of reading services to assist in the management of sight-threatening eye diseases.

     

    The Quality Assurance Administrator will support complaint handling, documentation, and change control throughout the organization by maintaining, updating, creating, routing for approval, archiving, and disposition of documents according to Quality System Requirements and Quality Management System, and maintain the Learning Management System and associated training records.

    Responsibilities

    • Responsible for receiving and initial evaluation of product complaints as well as inquiries in QA group, in collaboration with Customer Service group for Medical device Software.
    • Documents and tracks reported issues and problems in accordance with company guidelines and external regulatory requirements.
    • Route and implement change of documents (procedures, work instructions, forms, and specifications, and other related QMS or product documents).
    • Support timely document search and delivery during audits.
    • Work with internal department staff and management to ensure implementation of uniform practices in accordance with the principles of quality and good documentation practice.
    • Maintain Training Materials, courses and records through the LMS. (Topcon University)
    • Assist in other Quality Assurance tasks as required.              

     

    Qualifications

    Education & Experience:

    • Associates or higher degree in Computer Science or related discipline
    • Experience with Customer support for Software/ Hardware preferred

     

    Knowledge, Skills, and Abilities:

    • Familiarity with FDA QSR Requirements
    • ServiceMax and 123Compliance experience desired
    • 0-2 years of administrative experience in a regulated manufacturing environment (medical devices, aerospace, communications, automotive, etc.).

     

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