Experience

Ada Health

• Germany
• Hospitals and Health Care
• 200 - 300 Employee

• Quality Assurance Manager

  • Aug 2022 - Present

  Quality assurance manager, responsible for compliance with European Medical Device Regulation (EU MDR), FDA and other regional regulations for artificial intelligence medical devices, to ensure patient safety. Main missions: - Lead Change Control Board, drive Change Control processes, and facilitate discussions between relevant stakeholders to assess and execute QMS and product changes - Approve the Medical Software Products releases Documentation - Manage the compilation and maintenance of the the technical documentation for medical devices manufactured by Ada Health - Manage and continuously improve the QMS Training process, by the identification of training needs of direct collaborators and contractors - Lead the QMS Document and Records Control process - Contribute to CAPA process to determine root cause of non-conformance and support all relevant CAPA steps - Establishing and revising the current quality processes in cooperation with relevant stakeholders - Contributing with the review of nonconformance records to determine disposition, root cause and need for corrective and preventive actions - Provide training sessions to relevant parties Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Systems Manager

  • Mar 2021 - May 2022

  -Led the QMS performance development of the manufacturing site -Ensured the control of quality processes and KPIs -Assessed and performed regulatory intelligence (e.g., cGMP Annex 1) and implementation of compliance action plans -Managed supplier quality assurance -Managed customer audits, inspections by authorities and ensured an internal audit program -Led the risk and change management process -Supervised documentation management: SOPs, logbooks, batch records, etc. -Monitored and optimised the Quality and GMP training -Ensured GMP Data Integrity -Supervised the management of periodic reviews of production and laboratory equipment Show less



bioMérieux

• France
• Biotechnology Research
• 700 & Above Employee

• Senior Medical Scientist & Medical Training Lead

  • Sep 2018 - Feb 2021

  -Designed and monitored over 15 BioFire Post-Market studies-Collaborated with key researchers on worldwide “Health Economic Outcome Research (HEOR)” studies and clinical utility evaluations-Evaluated potential investigator-initiated studies as a member of the Study Evaluation Committee-Supported commercial teams by writing publication summaries to contribute with the adoption an educational database of the BioFire products-Managed and monitored medical training processes for commercial and scientific teams worldwide-Identified training needs and developed medical training programsMain achievement:Successful implementation of a worldwide medical training program for English and Spanish speaking audiences; and the construction of an evidence database about the medical and health-economics value of BioFire products. Show less

• Quality Manager - Global Supply Chain

  • Apr 2015 - Aug 2018

  -Implemented, maintained, and improved a Quality Management System to comply with ISO 13485, MDSAP, GDP and country regulations-Created and deployed corporate quality directives -Led process performance reviews-Reviewed, streamlined and simplified processes and procedures-Evaluated the QMS performance of third party logistics-Ensured the control of quality processes and KPIs-Assessed regulations and established compliance action plans-Managed supplier quality assurance-Managed external audits and regulatory inspections-Audited external suppliers and third party logistics-Ensured a risk management process, change control and CAPAs-Supervised documentation management-Monitored and optimized the Quality and GMP training for global supply chain-Developed practical ways to identify and meet business goals-Acted as quality leader for global projectsMain achievement:Designed and deployed the “Cold-Chain Management Project” throughout all bioMérieux subsidiaries worldwide. Show less

• Quality/Regulatory Affairs Manager - Technical Director

  • Apr 2011 - Mar 2015

  • Implemented, maintained, and improved a Quality Management System to assure compliance with the ISO 9001 requirements, country regulations, and corporate directives.• Led continuous improvement strategy, Quality System Management Review and Key Performance Indicators analysis.• Assured implementation of an internal audit program.• Performed internal and external audits.• Managed Post-Market Surveillance and registration of new products.• Provided quality support to regional distributors and customers.• Represented bioMérieux as the main regulatory contact with the local health authority. Show less

• Application Specialist - Trainer in IVD

  • May 2008 - Dec 2013

  • Provided training and support to bioMérieux customers and distributors, for the use of IVD solutions for microbiology and immunoassays. • Provided trouble-shooting expertise in the infectious diseases-immunoassay segment.



Clínica Medellín

• Colombia

• Blood Bank and infectious diseases bacteriologist

  • Jan 2007 - May 2008

  • Performed IVD tests for the screening of infectious diseases of blood components. • Participated in local blood donation campaigns. • Performed IVD tests for the screening of infectious diseases of blood components. • Participated in local blood donation campaigns.



Colegio Mayor de Antioquia

• Colombia

• University Teacher: Hematology and blood bank

  • Jul 2007 - Dec 2007

  Professors assistant on Hematology and Blood Bank with contents and execution of academic programs Professors assistant on Hematology and Blood Bank with contents and execution of academic programs