Quality Assurance Project Lead South Cluster

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/85qmtf

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. You will lead process improvements and contribute to building a strong quality culture within a global logistics environment. This position offers hands-on impact in shaping healthcare project delivery and regulatory compliance.
Responsabilità 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
Conduct risk assessments of QMS processes and mitigate risks
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
Requisiti fondamentali 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
Strong communication skills and ability to present to various levels
Experience with technical writing of documentation a plus
MS Office proficiency (Word, PowerPoint, Excel)
Knowledge of electronic Quality Management System an advantage
Ability to prioritize decisions with significant risk
Ability to network and collaborate with internal and external teams
Identify gaps and implement process improvements
Coordinate improvement projects and implement quality-critic

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/85qmtf