Bausch Health

  • Principal Quality Systems Specialist - Medical Device

    Location US-NY-Rochester | US-NJ-Bridgewater
    Job ID
    12828
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Support the implementation of EU MDR into the Quality Management System.

    Responsibilities

    The EU MDR Principle Quality Systems Specialist will support the implementation of EU MDR into the Bausch Health Quality Management System (QMS) by:

    • Leading Quality Management System discussions on the implementation of EU MDR
    • Lead EU MDR process owners on key areas for considerations with implementation tasks as it relates to the QMS
    • Effectively communicate key QMS project details to the project team, business stakeholders, and business leaders
    • Driving assessments of the EU Medical Device Regulation (MDR) impact on quality management system requirements
    • Ensuring QMS project activities and deliverables are complete to meet tight schedules.
    • Driving improvements in Quality System processes such as Complaints, Change Management, Document Management, Training, and Records management
    • Author / develop quality management procedures / documents.

    Qualifications

    • Bachelor's Degree (or) equivalent experience (reference experiences) in the Medical Device industry
    • Highly proficient with Microsoft Excel, Word, Power Point, & Project
    • Ability to lead & influence required
    • This position may require up to 10% travel
    • Excellent planning and prioritization skills with the ability to multi-task and adapt
    • Minimum ten (10) years of relevant experience required (preferable Medical Device, compliance, etc.)
    • Proven to effectively communicate both up and down the organization and maintain a customer focus.
    • Excellent written and verbal communication skills
    • Having a thorough knowledge of existing Quality management systems and infrastructure in use within Bausch Health

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    To learn more please read Valeant’s Job Offer Fraud Statement.

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