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Senior Specialist Quality Systems EMEA

Henry Schein • Hesse, Germany
100% English First
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Job Specifications & Overview

  • Employer: Henry Schein
  • Location: Hesse, Germany
  • Employment: Fulltime
  • *POSITION TITLE:**
  • *Senior Specialist Quality \& Regulatory Affairs EMEA**
  • *DEPARTMENT:**

    • Quality Systems  \& Regulatory Affairs EMEA

  • *COMPANY:**

    • Henry Schein

  • *LOCATION:**

    • Hybrid /TBD

  • *REPORTS TO:**

    • Snr . Director Quality Assurance \& Regulatory Affairs EMEA

  • *GENERAL SUMMARY:**

    • Supports EMEA\-wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow\-up on identified issues and support countries in implementing solutions within the Global Distribution Group Henry Schein Sites in EMEA.

     ·      Supports EMEA\-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.

    ·      Supports to perform quality \& regulatory visits and /or audits  to countries and issues gap analysis, ensures CAPA follow\-up  and related documentation on identified issues and support countries in implementing solutions.

    ·      Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow\-up on decided actions with related functional / country QA/RA Lead.

    ·      Support and assistance to Exec. Director QA \& RA EMEA and the EMEA QA/RA Team

    ·      Support to multiple projects, tracking timelines, and ensuring successful outcomes for EMEA\-wide QA/RA initiatives.

    ·      Maintenance of eQMS and Quality Document Management Tool

    ·      Oversight of change control activities and CAPA follow\-up, timely closure

    ·       Provides support to the country QA/RA Teams in Quality related topics to ensure compliance according GDP and MDR.

    o   Implementation of regulatory requirements and continuous improvement, support to ongoing transformation projects and product launch activities

    o   Support roll\-out eQMS implementation in identified countries.

    o   Inspection readiness initiatives and to roll\- of required tools

    o  Conduct and oversee quality training and compliance communications.

    o  Assits PRRC and EC Rep responsibilities such as adverse event reporting, post\-market surveillance and FSN management

    o  Other tasks and projects as needed