For our Quality Assurance Department, based in Roncello (Italy), we are looking for a:
EU Distribution Center Quality System Specialist
Supporting the QA and Supply Chain Departments to develop and sustain the Quality and Environmental Management System in the European Distribution Center in line with the required industry standards (including ISO and medical Devices regulations), accreditation requirements and business requirements, through existing and new procedures.
- Evaluating the compliance of the Supply Chain processes with the requirements of the ISO 13485, ISO 9001 and ISO 14001 standards applicable to the management system of the European Distribution Center;
- Managing the documentation of the quality management system, monitoring its updating status and the training ‘to the personnel
- Monitoring the non-conformities of the management system, managing the corrective and preventive actions by following their assignment, follow-up, closure and verification of effectiveness;
- Monitoring the process KPIs, intervening with corrective actions and process improvement proposals;
- Supervising and supporting the compliance of the Supply Chain processes at the EU Distribution Center with all the general obligations applicable to the European Importer, as required by the MD and IVD Regulations.
- Supporting the Supply Chain Management in the definition, planning, implementation and review of the supply chain processes, suppliers management, changes, validation activities and trainings;
- Supporting the certification bodies, the notified bodies and the suppliers in external audits of the management system.
Knowledge & Experience required for the position:
o At least 5 years of experience gained in the Medical Device/Pharma Supply Chain field, in Quality Assurance/Quality Control roles
· Education: Degree in scientific disciplines
· Additional Skills/Knowledge:
o Knowledge of international standards, with particular reference to ISO 13485
o Knowledge of IVD/MD Directives and Regulations
o Knowledge of GDP
o Knowledge of process validation
o Strong Computer skills: Office package / SAP
o English language: level C1
o Other languages: Italian and Spanish preferable
o Auditing / Compliance skills to identify and manage risk compliance
o Statistical analysis
o Project management skills
o Competences in lean solutions
We offer a full-time permanent contract. It’s required international mobility (travels up to 25-30% of working time).
At Werfen, worldwide leader in the in vitro diagnostics market, consideration and enhancement of people are a key factor for growth and success for the entire company. The possibility of working in an international organization, the constant attention to people and the possibility to emerge and grow professionally are some of the main elements that characterize our corporate culture. We want people to choose to work in Werfen because they share our same values.
Are you the person we are looking for?
Send us your resume or CV by clicking HERE and join the Werfen Team!