Diego Salerno

Development of QMS procedures (SOP's) at Zimmer corporate level following the regulations ISO 13458; Management of customer complaints; Management of internal non-conformity; Implementation of FSNs and FSCA; Management of relationship with the Italian Competent Authority; Registration of medical devices marketed in Italy; Conduction of internal and suppliers Audits; Management of Risk Management process (ISO 14971); Management of Calibration and Validation activities; Management of CAPA

Development of QMS procedures at corporate level (FDA 21 CFR part 820 e ISO 13458); Support the Medical Device Vigilance System; Assure all products remain in compliance with MDD; Assist in preparation of post-market surveillance programs; Take lead role of cross functional teams in case of larger quality problems; Management of the third party assessments for the compliance to: IEC 60601-1, 60601-1-2, 60601-1-4, 60601-2-16, ISO 14971; Establish the Project Quality Plan describing the project strategies.

Preparation of Test Plan strategy for V&V, Test Method Validation, V&V test input/output (protocols, test results, reports); Supply professional Quality Engineering support in the Design, development and manufacturing activities; Device and component verification and validation in support of development and manufacturing activities; Participate in Design Reviews as required and lead FMEA; Internal Audits and Corporate and Suppliers assessments; Conduct internal investigations.

Implementation of ISO9001:2000 and BRC/IoP certification; Manage the Glass, Ceramic and Brittle Plastics/GMP, Pest Control and Microbiological Analysis procedures; Manage a team of 3 QA Technicians; Manage QA activities (Product/Process and Hygiene Audits, Quality Statistics, FMEA, Process Capability, Doc./Records); Manage the internal investigations of Customer Complaints; Maintain Product Specifications Database; Planning and coordinate R&D Projects, Managing trials; Hosting Customer QA visits and audits.