Quality Site Lead-(Mirandola, Italy)

5 giorni fa


Modena, Italia Altro A tempo pieno

Quality Site Lead -(Mirandola, Italy) at TransMedics, Inc.Job DescriptionLocation: Mirandola, ItalyThe Quality Site Lead will play a pivotal role in establishing and executing the Quality Management System (QMS) at a new medical device R&D disposables and pilot manufacturing site. This individual will serve as the on-site quality authority and primary liaison between corporate quality leadership and site operations, ensuring all activities align with global QMS standards, regulatory requirements, and business objectives.ResponsibilitiesLead the deployment of the company’s established QMS at the new site, ensuring full compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory standards.Translate corporate quality policies and procedures into site-level processes, documentation, and training where appropriate.Develop, implement, and maintain quality procedures specific to site operations (e.g., incoming inspection, manufacturing quality controls, calibration, document control, CAPA, and supplier management).Support site R&D Team on the tasks related to Quality and act as point of reference between the R&D team and Quality Team in Andover, MA, USA.Serve as the quality lead for all site startup activities, including facility qualification, utilities qualification, environmental monitoring setup, and equipment installation, validation and maintenance.Partner with Engineering, Manufacturing, and Operations teams to ensure quality requirements are incorporated into all aspects of site design and readiness.Support process



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