Scope: EMEA selling entities: ILS France, ILS Benelux, ILS Switzerland, ILS UK, St Aubin Distribution Center. / CSS and OTT divisions.
Global mission: Under the responsibility of the Quality Assurance manager, the Quality Assurance associate:
. participates to the implementation and the maintenance of the Quality Management System covering all EMEA selling entities cited above in accordance with Corporate guidance and any other necessary standard/regulation (ISO 13485).
. supports all EMEA departments in setting up and deploying harmonized and compliant processes for marketing, selling and distribution activities within the EMEA area. These activities include, but are not limited to launch of new products, acquisitions, new flows of products, all new business project, new software implementation, compliance issues, etc.
- Quality System:
. Build and maintain the Quality Management System in accordance Corporate guidelines and any other necessary standard/regulation (ISO 13485)
. Manage documents in Agile: (DCO, ECO, MCO / Agile originator, Agile Analyst and Implementation Analyst roles) and notify users through the appropriate way
. Maintain the EMEA training matrix up to date
. Organize and perform Quality Management System training for new arrivals
. Maintain Quality Agreements up-to-date with internal / external manufacturing sites
- Product Compliance:
. Perform investigations for complaints related to distribution issues
. Manage nonconformities process
. Keep abreast of current HHE, relay information to the selling entities, and participate to the “Field Safety Corrective Actions” if needed.
. Participate to the CAPA management.
. Movex ERP System: in charge of the Quality items’ reclassification / lot number creation / expiry date completion, and Bill Of Materials’ management in routine
- Business support:
. Build and maintain transversal processes for new products, acquisitions, business projects and compliance issues and any organizational changes impacting the Quality Management System.
. Ensure the PMAP process is aligned with Integra policies and Regulatory requirements.
. Collaborate with European and US Quality teams to ensure quality concerns are addressed early in the process and appropriate processes are developed.
Perform internal audits.
. Perform all other related duties as directed by management,
. Perform training according to ISO, GxP, Policy, any medical devices or Tissue products regulatory requirements.