Quality Systems Specialist - Leuven, België - Terumo

    Terumo
    Terumo Leuven, België

    3 weken geleden

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    Beschrijving

    Job Summary

    As part of this department, the main responsibilities of the Quality Systems Specialist are to support the Terumo Europe organisation to comply with the applicable quality system requirements for document control and training, by active participation in process improvements, by performing quality audits and leading the follow up of related non conformities.

    Your team, led by Bert Pipeleers, works from our HQ based near Leuven Belgium. We offer a hybrid way of working with a minimal presence of one day in the office. In this role you'll liaise with various stakeholders throughout our EMEA organisation.

    We only accept applications of candidates that are legally entitled to work in the EU.

    Job Responsibilities

    1. Execute and support quality systems audits

    • Participate in the internal audits of Terumo Europe

    • Support regulatory, corporate and customer audits as subject matter expert for document control and training.

    2. Maintain the training QMS process in Terumo Europe

    • Maintain the training process and keep applicable procedures aligned with current standards and regulations.

    • Support people managers of the different departments and HR in defining training requirements in the learning plans and assessments, based on knowledge of QMS requirements in the different areas.

    • Review quiz assessments on QMS procedures.

    • Represent QS in board to assess to which learning plans new procedures should be linked.

    • Support HR in maintenance of the e-QMS learning module.

    • Responsible for non-conformity handling related to training issues (including audit non conformities): investigate CAPA need, guide investigation to the root cause of the non-conformity and review corrective actions proposed. Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the non-conformity.

    • Define and follow up of KPI's to monitor the training process.

    3. Maintain the document management system in Terumo Europe

    • Maintain the document/record control process and keep applicable procedures aligned with current standards and regulations.

    • Give training on document management system in e-QMS, technical writing of SOP's and archiving of QMS records.

    • Supervise group of master file coordinators

    • Measure process performance with KPI's

    Profile Description

  • University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience
  • Profound knowledge of the QMS standards ISO 13485 and FDA 21CFR part 820 in order to be able to define learning plans in the different departments
  • Experience as (internal) auditor as a preference
  • Good working knowledge of English (written and spoken).
  • Team player with strong communication skills to collaborate with a large variety of stakeholders

    • Offer

    Working for Terumo means contributing to society through healthcare.

    We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.

    Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work. For the Regulatory Affairs team a regular presence in the office close to the manufacturing plant, combined with work at home is the guideline.

    Terumo offers an attractive salary and benefits package. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike and we offer 12 additional holidays on annual basis.