25 set - Milano
Experteer Italy
Specialista Senior / Project Manager
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.
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- 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
- Track project progress and capture lessons learned
- 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
- Strong communication skills and ability to present to various levels
- Experience with technical writing of documentation a plus
- Knowledge of electronic xysqume 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-critical processes
- Strong organizational, time management and planning skills
In this role you drive quality assurance across healthcare projects, ensuring a robust QMS aligned with ISO 9001, ISO 13485, EU GMP, and EU …
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