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Quality Systems Specialist Doc Control & Training

Job description

We are looking for a QS Specialist Doc Control & Training for a leading medical devices company, with production units in Belgium and the UK. As part of the EMEA Regulatory & Quality Division, the main responsibilities of the QS Specialist Doc Control & Training are to support the EMEA 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.

RESPONSIBILITIES

Execute and support quality systems audits

    • Participate in internal audits
    • Support regulatory, corporate and customer audits as subject matter expert for document control and training
Maintain the training QMS process
    • 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

Maintain the document management system

    • 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 masterfile coordinators
    • Measure process performance with KPI’s
Skills and personality
  • 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 Dutch and English (written and spoken)
  • Team player with strong communication skills to collaborate with a large variety of stakeholders
Contract

Executive search

Experience

minimum 3 years

Education

Higher Scientific Degree

Languages

Dutch, English

Sector

Medical Devices

Region

Leuven

Job type

Full-time

 
 

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