Quality Assurance Project Lead South Cluster

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8nxlmg

Overview In this role you drive quality assurance across healthcare projects, ensuring a robust QMS aligned with ISO 9001, ISO 13485, EU GMP, and EU GDP. You'll coordinate QA activities, support audits, risk assessments, and change controls, and partner with internal and external stakeholders to deliver compliant, efficient project outcomes. This position offers hands-on impact in shaping healthcare project delivery and regulatory compliance. Coordinate and maintain QMS per ISO 9001 and ISO 13485, and EU GMP/GDP guidelines Assess and support projects from quality and compliance perspectives Lead QMS setup in new buildings and client implementations Support external audits and regulatory inspections within project scope Assist with process validation for new processes and buildings Support design qualification for new buildings/clients Track project progress and capture lessons learned Coordinate process improvement projects across departments Develop and provide training for client implementations Create change controls for applicable projects Bachelor's degree in Sciences Proven experience in ISO 9001 and/or ISO 13485 GMP and/or GDP knowledge a plus Experience with Root Cause Analysis tools (e.g., 5 Why's, FMEA) and Project Management Proficient in English and Italian; Spanish a plus Experience with technical writing of documentation a plus MS Office proficiency (Word, PowerPoint, Excel) Knowledge of electronic Quality Management System an advantage Ability to network and collaborate with internal and external teams Coordinate improvement projects and implement quality-critical processes Suggest training opportunities Strong organizational, time management and planning skills Flexible in

working hours
collaboration ISO 9001 knowledge ISO 13485 knowledge GMP/GDP knowledge

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8nxlmg