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  • Sr. RA/QA Specialist

    Requisition ID
    2018-2936
    Experience Level
    Specialist
    Industry
    Medical
    Employment Status
    Regular Full-Time
    Location : Location
    US-CA-Livermore
    Category
    Quality Control
  • Overview

    Performs a variety of Quality Assurance and international regulatory activities that ensure compliance with FDA, EU and ISO regulatory requirements and reports to the Manager, Regulatory and Clinical Affairs.

    Responsibilities

    • Oversees and manages the Complaint process.
    • Facilitates the non-conforming material process.
    • Coordinates Material Review Board (MRB) disposition with Quality Department, Purchasing, Engineering and Manufacturing as necessary.
    • Conducts material movement transactions from and to MRB/NCR (Non-Conformance Report) Inventory on the ERP System.
    • Maintains country specific registrations.
    • Supports international regulatory product submissions, e-Doc change control system administration.
    • Analyzing/trending and reporting of global quality data.
    • Provides support to Regulatory Affairs/Notified Bodies/FDA audits.
    • Processing regulatory documentation (e.g. notarization, apostilles, legalizations).
    • Any other duties, as assigned by Manager, Regulatory and Clinical Affairs.

    Qualifications

    Education & Experience

    • AA degree in RA/QA or applicable work experience
    • 6+ years in a Regulatory Affairs/quality assurance role at a medical device company
    • Supported international regulatory product submissions and 510k submissions
    • Participated in a Complaints process of reporting and tracking complaints
    • Supported CAPA (Corrective and Preventive Action) processes
    • Participated in QA/Regulatory cGMP/ISO 13485 audits
    • Experience with filing eMDRs and Vigilance Reports

    Knowledge, Skills & Attributes

    • Must have good verbal & written communication skills
    • Strong ability to interact with multiple organizations to insure timely closure of complaints
    • Familiarity with FDA 21 CFR 820 and/or ISO 13485: 2016
    • Must be detailed & quality oriented and able to work independently with minimal directions
    • Proven proficiency using Computer business software; such as, Microsoft Word and Excel (especially for graphing and trending purposes)

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