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Gondrecourt-le-Château

    Senior Complaint Handling Specialist-Quality Systems - St Paul, United States - Spineology Inc.

    Spineology Inc.
    Spineology Inc. St Paul, United States

    1 month ago

    Default job background
    Description

    Overview:

    • Responsible for providing leadership to the quality team regarding the complaint handling process- in maintaining and improving key elements of the complaint handling system.
    • Manage implementation of complaint handling software in transition from a paper-based system to electronic.
    • Receive, review and accurately document product complaints.
    • Support product returns in line with complaint handling process.
    • Collect, analyze, and trend product data as it pertains to the complaint handling process.
    • Assist in internal investigation process for returned products including direct interaction with design engineers and product managers.
    • Aid in oversight of day-to-day department activities.
    • Lead internal update meetings as it pertains to complaint handling.
    • Own complaint quarterly trending and analysis as it pertains to Management Review and Post-Market Surveillance.

    Background & Requirements:

    • Bachelors degree or higher.
    • 4+ years complaint handling experience in medical device or other regulated industry preferred.
    • MN in-office required.

    Knowledge, Skills & Abilities:

    • Ability to effectively interface with excellent communication skills; both written and oral.
    • Self-starter who can work with minimal direction.
    • Project management, critical thinking, and problem-solving skills are essential.
    • Working knowledge of PCs pertaining to file management, word processing, database, and spreadsheet software programs.
    • Experience working under FDA QSRs and ISO 13485 preferred.
    • Strong detail orientation and technical aptitude.
    • Proven record of dependability.
    • Effective organization and prioritization skills.
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