ESSENTIAL DUTIES AND RESPONSIBILITIESSupports EMEA-wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions within the Integral Distribution Group Henry Schein Sites in EMEA.
Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up and related documentation on identified issues and support countries in implementing solutions. Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up on decided actions with related functional / country QA/RA Lead. Support and assistance to Exec. Director QA & RA EMEA and the EMEA QA/RA Team Support to multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.
Maintenance of eQMS and Quality Document Management Tool Oversight of change control activities and CAPA follow-up, timely closure Provides support to the country QA/RA Teams in Quality related topics to ensure compliance with GDP and MDR.
Implementation of regulatory requirements and continuous improvement, support to ongoing transformation projects and product launch activities Support roll-out eQMS implementation in identified countries. o Inspection readiness initiatives and to roll- of required tools o Conduct and oversee quality training and compliance communications. Assists PRRC and EC Rep responsibilities such as adverse event reporting, post-market surveillance and FSN management Other tasks and projects as needed.
QUALIFICATIONS
- Experience: Quality Management, Project Management experiences, Medical Device Experiences, Pharmaceutical (GDP) experience is a plus MDR /IVDR Regulations/ ISO 13485 Validation of (computerized systems) and Risk management (FMEA) knowledge is a plu
📌 Senior Specialist Quality (Madrid)
🏢 Brasseler USA
📍 Madrid
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