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Surgical Logistic Quality Coordinator

Job description

Responsible for all QA tasks and projects concerning Logistical Operationals Surgicals. This needs to be strictly executed against the relevant procedures of GMP, quality and environment.

JOB DESCRIPTION

  • Act as a SPOC for the Head Supply Chain and ICDC Puurs (GJFA 3, Functional Manager) and other corporate/international functions, this to enable the department to meet the business objectives.
  • To report to/support the Head of CPK QA & Surgical Logistics (GJFA 4, Operational Manager) in all aspects of the role (including budget control and preparation) 
  • Responsible for the control of quality of the Surgical Hub Warehouse In Bornem
    • Lead escort for external audits (eg Notified Body)
    • Manage (immediate) product holds
    • Make and maintain/keep up-to-date relevant (corporate) procedures/guidelines/regulations
    • Periodical review of warehouse-audits
  • Responsible for follow-up of key large projects (eg warehouse systems/ ERP systems) in the Surgical Logistical departments from a QA perspective
  • Support Logistical activities for Surgicals from a QA perspective
    • Follow-up for timely release of return and redress dossiers
    • Responsible for making any relevant monthly reports, quad reports, APR, organizing a quality review for Logistical Surgical QA
    • Approval, review and follow-up of product-deviations, external logistical complaints with impact on product-quality
    • Evaluation and follow-up of the add-aftering/re-dress process
    • Alignment of logistical processes with relevant procedures/regulations
    • IGM Business:
      • Supporting the Lead IGM Bussiness Coordinator when applicable (eg Record Management); organization of sensibilisation and training concerning Records Management when necessary.
      • Ensure correct records Management in the department (like required by the IGM/Records Management Policies, translated in local procedures)
  • Supervision of logistical QA team in Surgical Hub Bornem (including providing objectives, coaching and training) and ensure continuity (ensure back-up system).
  • Ensure that the QA organization contributes information, knowledge and completes assigned actions within multidisciplinary teams (e.g. risk assessments, change control, audits, batch record review and completion etc.)
  • Follow-up and control of SQA related activities concerning Logistical Partners
    • Ensure availability of QA Agreements/Risk Assessments with relevant suppliers/contract manufacturers
    • Approval and follow-up of complaints, deviations coming from suppliers and contract manufacturers
    • Follow-up of a periodical review for suppliers and contract manufacturers
    • Planning and follow-up of the screeningsplan of suppliers and contract manufacturers
    • When certified for audits: executing of external audits
Skills and personality
  • Fluency in English and Dutch and ability to read and understand French
  • Minimum 5 years of experience in quality and preferably logistic department
  • Experience with independent way of working with great sense of responsibility
  • Experience with communicating across different levels within the organisation (eg global roles or head supply chain Puurs and ICDC) in a professional, diplomatic and independent way
Contract

Executive search

Experience

minimum 5 years

Education

Master's Degree

Languages

Dutch, English

Sector

Medical Devices

Region

Puurs

Job type

Full-time

 
 

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