Cluster Leader Medical Devices QA&RA Consultant at TS Quality &EngineeringSupporting different medical devices companies (class I to class III), in different fields including implantable medical devices, for QMS remediation and transition to EU MDR 2017/745. Execution of FDA Mock Inspections on class II and class III Medical Devices companies to supporting them for preparation to FDA inspection and/or remediations.

Gambro is a WW company with main business in development, production & distribution of systems for therapies on patient renal failure, both cronic and acute patients.VP Global QA/RA Disposables Operations includes responsibilities & authorities on: - 4 plants for bloodlines manufacturing - 3 plants for solutions (R&D + Manufacturing) - 3 plants for Dialyzers (R&D + Manufacturing)Head of Global Supplier Quality Management includes responsibilities & authorities on suppliers providing raw material/ components/products/services delivered to any Gambro manufacturing plant producing dialysis machines &/or disposables.

Quality Assurance and Regulatory Affairs proven Executive Leader with over 28 years improving Quality System Design&Development and Operation processes, balancing business support and compliance, products Design Assurance, Suppliers Management strategy and execution, organization restructuring, alignment and effectiveness, crisis management and customer driven quality improvements. Multi-region and international experience at plant and corporate levels to drive quality and compliance strategies from vision to sustainment. Extensive experience in compliance and facilities remediation covering the whole product life-cycle. Strong results oriented leadership with focus on team building, people development and personal accountability.

Head of Quality Assurance & Regulatory Affairs in a BVI plant located in RomeCoordinating a team of 4 consultants in QA and 5 consultants in RA for:1. Revamping of the whole Quality Management System and all company processes2. Supporting the day-by-day business (R&D and Manufacturing) of the company producing Ophthalmic products (equipment, disposables and reusable)3. Re-certification of the plant on ISO 9001: 2015 and ISO 13485: 20164. Implementation of all QMS changes supporting EUMDR5. Management of all QMS processes including FSCAs and pertinent Regulatory Authorities6. All class I medical Devices moved to EUMDR7. All class IIa and IIb medical devices on the way to be moved to EUMDR

1. . Philips Corporate QMS definition and implementation for compliance to ISO 9001:2015; ISO 13485: 2016, FDA Quality System Regulation and new EU Regulation 2017/745 on Medical Devices.2. Validation of Software tools (Non Product System Software) supporting QMS processes & others, ..3. Roll-out of QMS processes, procedures and supporting tools to all Philips BGs, BGs and Markets4. Working as expert point of contact and support for all Philips PQMS Leaders from the different BUs/BGs/ Markets