Experience

Methinks AI

• Spain
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior QA/RA Manager at Methinks

  • Dec 2020 - Present



Huma

• United Kingdom
• Software Development
• 100 - 200 Employee

• Regulatory & Compliance at Huma

  • Sep 2019 - Dec 2020

  - ISO 13485 Quality Management System Implementation and Improvement; - MDR 2017/745 Compliance; - EN 62304 Implementation; - ISO 14971 Implementation; - Internal/External Audits; - ISO 27001 implementation; - Design and Development Activities for Software as a Medical Devices; - Collaborated with Pharma Companies for the development of SaMD products; - ISO 13485 Quality Management System Implementation and Improvement; - MDR 2017/745 Compliance; - EN 62304 Implementation; - ISO 14971 Implementation; - Internal/External Audits; - ISO 27001 implementation; - Design and Development Activities for Software as a Medical Devices; - Collaborated with Pharma Companies for the development of SaMD products;



Quantium Medical

• Spain
• Biotechnology Research
• 1 - 100 Employee

• Quality and Regulatory Affairs Associate

  • Jan 2017 - May 2019

  Working in the Production and Quality and Regulatory Team: - QA Testing of depth anesthesia monitors (Class IIb Medical Devices);- ISO 13485 - Quality Management System Maintenance and Improvement; - Assisting External Audits (Korea Good Manufacturing Practice (KGMP), ISO 13485, CE Mark Certification);- CAPA and Complaint Management;- Trainer for Class IIb Medical Devices to the Fresenius Kabi Technical Support teams;- Preparation for Manufacturing transfer to the Fresenius Kabi facilities (France);- ISO 14971 - Risk Management. Show less

• Biomedical Engineering final project of the degree

  • Jul 2016 - Jan 2017

  Study on the Measurement of the Heart Rate Variability, Skin Conductance and Electroencephalogram Signal for the Quantification of Pain.Participated in the Competition of the Annual Congress of the Spanish Society of Biomedical Engineering (CASEIB 2017) as a student representative of the Universitat Politècnica de Catalunya (UPC) presenting my final project of the Biomedical Engineering Degree.

• Biomedical Engineering Internship

  • Mar 2016 - Jun 2016

  Biomedical Engineering Internship FDA Submission, Verification & Validation Testing for Class IIb Medical Devices. - FDA 510(k) Product Submission;- Hardware testing;- Matlab environment activities.