• Quality Auditor

    Posted Date 3 weeks ago(10/26/2018 12:55 PM)
    Job ID
    2018-1347
    Type
    Regular Full-Time
    FLSA Status
    Non-Exempt
  • Company Overview

    LeMaitre Vascular is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. We develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionalists.   LeMaitre Vascular is publicly traded on NASDAQ (Ticker Symbol: LMAT).

     

    LeMaitre Vascular's core hiring principle is to find and hire smart, motivated people.  This mission leads to providing our employees with challenging opportunities for personal and professional growth, as well as the growth of the company. Our employees have dedication and passion for their work. Each day they know they can make a difference. While working at LeMaitre Vascular you will be surrounded by talented and passionate co-workers and owners.

     

    Overview

    The QA Auditor will serve a support role for the QA staff by creating and managing donor charts to make ready for MD review and release.  This process involves gathering of medical charts from various sources and compiling into a organized folder for quality review and preparation for MD review. This position will also close charts by completing final documentation related to implantation of donated tissue.

     

    Responsibilities

    • Adheres to Quality Management System(QMS) and all documents associated with program
    • Ensures compliance and adheres to Good Tissue Practices established by FDA 21 CFR Part 1271, AATB and company procedures and policies
    • Auditing Charts – sections 1/3, reporting and Data Entry
    • Destruction / closing of charts
    • Review of charts after MD approval: labels/spec sheets/sign off implant packet – update distribution spreadsheet
    • Distribution/Implant forms
    • Other duties as assigned by Supervisor or designee.

    Qualifications

    • Quality experience QA/QC in healthcare/Tissue Bank/biotech
    • Experience reviewing Donor charts a plus

    EEO Statement

    In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

     

    This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

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