Paulo Ramos
Director, Quality Management System(Qms) and Learning Management System (Lms) @Premier Research
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WORK HISTORY
Director, Quality Management System(Qms) and Learning Management System (Lms) @Premier Research
GB
Strategic oversight of Premier\' Quality Management and Learning Management Systems, enhancing training impact and regulatory compliance. Collaborating with cross-functional teams to streamline processes, resulting in improved operational outcomes. Acting as the primary contact for QMS & LMS initiatives, driving continuous improvement in system integrity.
EDUCATION
Universidade Europeia
Bachelor's degree, Human Resources Management/Personnel Administration, General
Egas Moniz School of Health & Science
Post-Graduation in Occupational Health and Safety - ISO 45001 Auditor, Health and Safety
SKILLS
ABOUT PAULO RAMOS
Highly skilled professional with a proven track record in quality management and team collaboration. Adept at fostering a collaborative environment and mentoring teams. Effective communication and exceptional management skills have led to successful quality system implementations, evidenced by positive audit outcomes. With over 20 years of diverse experience, including 9 years in the Medical Device, FMCG, and Consumer Healthcare industries, I am a results-driven Senior Quality Manager committed to advancing quality systems and regulatory compliance. My career is defined by expertise in ISO 13485 & ISO 9001 certification, GMP compliance, and ensuring adherence to stringent global standards, including EU MDR regulation.I have successfully led organizations through complex certification processes, achieving and maintaining multiple accreditations while implementing robust Quality Management Systems (QMS). Partnering with senior leadership, I have delivered strategic quality improvements, resolved critical issues, and enhanced operational efficiency through innovative solutions.Notable achievements include:Designed, built, and implemented a comprehensive Medical Device ISO 13485 Quality Management System (QMS) from the ground up, leading to the successful launch of Unilever\'s first medical device in full compliance with the EU Medical Device Regulation (MDR 2017/745).Driving continuous improvement and process optimization across global operations by implementing electronic QMS systems and embedding a culture of quality and compliance across sites.Implemented a robust CAPA process by empowering training teams, fostering proactive problem-solving, and driving continuous improvement—effectively minimizing the occurrence of major non-conformities.My leadership approach is built on collaboration, adaptability, and an unwavering focus on driving excellence in quality, safety, and compliance. Skilled in remote team management, internal and external audits, and cross-functional collaboration, I excel at delivering value to customers and stakeholders alike.Core Skills:ISO 13485, ISO 9001, ISO 45001, ISO 27001, GMP ComplianceEU MDR, US FDA Regulatory KnowledgeISO 14971 risk assessment for medical devices, from implementation to continuous improvement.AI regulations, including ISO 42001SaMD and AI-driven medical technologiesProficient in IEC 62304Quality System Optimization & Continuous ImprovementCAPA, Root Cause Analysis, and Problem-SolvingStrategic Leadership & Collaboration with Senior ManagementInternal & External Audit Management
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