Surgical Logistic Quality Coordinator

Job Description
Position Purpose:
Coordination and supervision of QA Logistic Activities within QA Surgical Logistic department. This needs to be strictly executed against the relevant quality systems requirements, GMP and internally defined standards and procedures.

Major Accountabilities:
- Supervision of logistical QA team (Engineers(s) and Release assistant(s)) in Surgical Hub Bornem (including providing objectives, coaching and training) and ensure continuity (ensure back-up system)
- To report to/support the Site Quality Head in all aspects of the role (including budget control and preparation)
- Act as a SPOC for the Head Supply Chain and ICDC Puurs and other corporate/international functions, this to enable the department to meet the business objectives
- Responsible for the control of quality of the Surgical Hub Warehouse In Bornem
o Lead escort for external audits (eg Notified Body)
o Manage (immediate) product holds
o Make and maintain/keep up-to-date relevant (corporate) procedures/guidelines/regulations
o Periodical review of warehouse-audits
- Support Logistical activities for Surgicals from a QA perspective
o Follow-up for timely release of return and redress dossiers
o Responsible for preparing QA Logistic KPI Data for Management Review, Cockpit, quality Review Meetings
o Approval, review and follow-up of product-deviations, external logistical complaints with impact on product-quality
o Evaluation and follow-up of the add-aftering/re-dress process
o Alignment of logistical processes with relevant procedures/regulations
- 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.)
- 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)
- Monitoring and management of activities related to logistic suppliers, external warehouses, transporter & distributors
o Ensure availability of QA Agreements/Risk Assessments with relevant suppliers/contract manufacturers
o Approval and follow-up of complaints, deviations coming from suppliers and contract manufacturers
o Follow-up of a periodical review for suppliers and contract manufacturers
o Planning and follow-up of the screenings plan of suppliers and contract manufacturers
- Execution of the assigned internal and external project within QA

Key Performance Indidators:
• Delivery targets
• Budget on track
• QA-Continuity for Logistical Operations
• External Audits with conform results; timely executing of internal warehouse- audits
• Projects on track
• Training status of logistical QA organization
• Number of complaints / deviations and timely approval of them (internal or external)
• QA Logistic KPI data
• Distribution Release
• Up-to date QA Agreements / Risk Assessments

Minimum requirements Eduction:
Industrial engineer or higher (eg bio-engineer, pharmacist)

Experience:
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

Languages: Dutch (speaking and writing), English (speaking and writing), French (understanding)


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