- Experience in managing and implementing ISO 13485, MDR 2017/745 and 21 CFR Part 820 standards in relation to medical devices- Responsible for product release - Responsible for maintaining and integrating the QMS, drafting, managing and enforcing the operational procedures of the Organization's internal processes, ensuring ongoing compliance by all personnel involved. - Responsible for conducting certification audits by institutions and Notified Bodies. - Responsible for employee training on operating procedures and maintaining detailed records of such training. - Responsible for resolving customer complaints, CAPA and product recall activities. - Experience as supervisor and production coordinator to ensure the highest level of compliance and productivity on the production line. - Responsible for supply chain and involved activities such as: supplier qualification, planning and purchasing products and services, control and logistics. - Responsible for medical device design and development: experience in managing and coordinating project teams, developing project plans, product and project requirements definition (personnel, materials, technologies), and achieving project objectives by ensuring that the product is produced within the established time, quality, and cost (or within tolerance). I have experience in establishing procedures related to project and product (risk management, change control, usability).

Experience in: - Testing activities according to standards or implementing new test methods; - Project planning, time processing; - Failure analysis process; - Customer communication;- Project management and development;- Management and coordination of personnel;- Data analysis and statistical techniques; - Technical writing and documentation review; - Software programming;

Major accountabilities:- Supporting the manager in the selection, qualification, monitoring and revaluation processes of new and consolidated Suppliers;- Creating and maintaining pertinent Quality Management System procedures and work instructions (e.g.: SOP, WIN; General Quality Conditions, Purchase Specifications);- Managing and collecting quality records required by pertinent Quality Management System procedures and work instructions;- Monitoring Supplier performances, managing the calculation of quality indicators;- Managing purchased product Non-Conformities;- CAPAs implementation and evaluation;- Managing Initial Sampling process;- Managing activation of reduced inspection strategies;- Evaluation of process validation dossiers (IQ, OQ, PQ) in collaboration with internal Process Validation Department and Technical Office;- Writing Operating Instructions for test execution;- Testing, data processing and compilation of test report;- Communication with Suppliers about quality topics;- Cooperation with Technical Office to identify necessary improvements or modifications to the technical documentation (e.g.: product drawings, technical specifications);- Cooperation with Purchasing Office for the implementation of new purchasing sources and alternative sources identification;- Supporting role in Post Marketing Surveillance Department in case of Customer Complaints caused by outsourced productions;- Supporting role in Incoming Inspection Department, in case of complex product non-conformities;- Supporting role in Regulatory Office in case of new products registration or to renew existing CE product registrations;- Supporting the Manager during inspections of Certification/Notified Bodies, Competent Authorities and Agencies;

Development of a novel treatment for the functionalrestablishment of osteoarthritic cartilage of articular joint. In this study multifunctional hydrogels have been engineered as delivery systems of biological entities for cell-based therapies. The hydrogels have been designed in order to mimic the biological articular environment in terms of structure, chemical and mechanical features. The in situ enzymatic polymerization enables the injection of the material. System morphology, composition, rheology, citoxicity and biocompability have been in vitro characterized. Owing to its characteristics and mild conditions employed, the encapsulation of very unstable and sensitive cargoes is possible, highlighting its potential as a platform for a variety of biomedical applications.Knowledge of:- Preparation of chemical solutions;- Test strategies; - Calibration curve implementation;- Enzymology assessment;- Spectrophotometry and spectrofluometry;- Elisa assay;- Statistical data analysis;- Cell culture and cell line expansion;- Cell viability assay;- Practice of sterile techniques;- Cytotoxicity and biocompability assay;- RNA extraction and purification;- qPCR reaction;- Gel electrophoresis;- Light microscope;- Rheometer;- pH meter;- FTIR and DLS;- Dialysis;- Lyophilization;- Sonication;- Z-potential analysis;