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QS Specialist

Posted On:  16-Aug-2019
Job Category:  Operations, Quality & Engineering

At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates.

 

Terumo ERQDivision operating from Haasrode, Belgium, provides supporting services in regulatory affairs, quality systems and post market surveillance to Terumo internal and external customers on an EMEA basis.

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

RESULT SPHERES

  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.
  1. 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 Pilgrim 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.
  1. 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 REQUIRED
 

  • University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience
  • Minimum 3 years experience in quality department, including technical writing experience in medical and/or pharmaceutical field
  • 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
We offer a challenging role in a leading medical devices company, with production units in Belgium and the UK.
An interesting salary, combined with extra legal benefits 

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.

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