Topcon

  • Quality Assurance Specialist

    Requisition ID
    2018-2677
    Experience Level
    Specialist
    Industry
    Medical
    Employment Status
    Regular Full-Time
    Location : Location
    US-NJ-Oakland
    Category
    Regulatory
  • Overview

    Topcon Healthcare Solutions (THS), headquartered in Oakland, NJ, is a leading software engineering company of the eye care industry.  THS is responsible for R&D, engineering, marketing, sales, and support of software solutions to the global market.

     

    Topcon's mission is to make the impossible possible, by constantly innovating optical, imaging, and measurement technologies and developing new and advanced image management and networking solutions.  Our goal is simple: to provide the ophthalmic medical community with the most innovative and indispensable software solutions so that doctors and researchers can better serve patients, ultimately improving outcomes in eye and vision care. THS is newly established in 2017 to provide the most advanced software solutions to the global market. We focus on IoT, Cloud and AI technologies to enable “Healthcare through the eye”.

     

    The QA Specialist will support Complaint and CAPA handling as well as nonconformance investigations, to ensure company compliance according to Quality System Requirements and Quality Management System.

    Responsibilities

    • Responsible for analyzing and investigating of our software product complaints (related to medical device software) or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.
    • Develops or updates company complaint and inspection procedures to ensure issues are captured and investigations occurs, as well as proper documentation of complaints.
    • Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development.
    • Work closely with internal departments for resolution of CAPA and Supplier Corrective Action Requests.
    • May perform audits and risk assessments.
    • Assist in other Quality Assurance tasks as required.

     

    Qualifications

    Education & Experience:

    • BS or MS in Computer Science/Computer Engineering or related fields.
    • 2-3 years experience in a quality role within a software company or direct interaction with software solution complaints

    Knowledge, Skills, and Abilities:

    • Familiarity with FDA QSR Requirements
    • Ability to troubleshoot, diagnose and document technical complaints
    • ServiceMax and 123Compliance
    • Experience with Customer support for Software/ Hardware preferred
    • Ability to work independently and efficiently; good organizational and investigational skills; ability to follow detailed written procedures; able to handle multiple tasks simultaneously and prioritize accordingly;
    • Good communication skills, verbal and written; good analytical ability; ability to work well with others; good problem-solving skills; detail-oriented.

     

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