Aránzazu R. Email and Phone Number

Medical device compliance (ISO 13485, ISO 14971, MDR, MDSAP) - QMS Document control- Training management and onboarding - Complaint, NC and CAPA handling- Change management- Internal auditor- Supplier control and supplier auditseQMS transition and implementation Class I and IIb medical devices

Quality Assurance Manager at ProCanT (part of A3P Biomedical)IVD medical device development & compliance to ISO 13485, ISO 14971 & IEC 62304.

QA Assistant: Jan-AprilQA Manager: May-August• QA: Company QMS development and maintenance, documentation for IVDD product development.SOPs, Internal audits, Supplier audits, Process management, Non-conformities/deviation management, Change Control, CAPA, Risk management, Management Review, Measurement, Analysis and Improvement of processes, Records. • Project manager: medical software product development and documentation, including risk management (PRA), PLC, PRS, SRS, TRS, V&V, PME, PMS, and all documents required for an IVDD product-to-be in order to obtain its CE-mark and place it in the market.Obtained ISO 13485 Certification.IVD compliance:- IEC 62304- ISO 14971- IVDD (98/79/EC)

Consultant assignment with focus on Cell Culture at the Karolinska Institutet Biobank, Stockholm.Human sample reception, sorting, processing, storing and withdrawal. Lymphocyte isolation from human samples (blood, bone marrow).LIMS documentation and tracking.Use of automated sorting and sampling robots.

Vascular Biology UnitDepartment of Medical Biochemistry and Biophysics (MBB)Supervisors: Josefin Skogsberg & Erika FolestadCo-supervisors: Dick Wågsäter & Ulf Eriksson"Novel aspects of atherosclerosis: focusing on new target genes and the effect of cholesterol-lowering"Led the experimental section of several projects related to Atherosclerosis, Leukocyte migration, Cholesterol-lowering effect and Abdominal aortic aneurysm in murine models. Generated hypothesis, designed studies, performed experiments, generated and analyzed data, optimized protocols, communicated results, composed manuscripts and published in scientific journals.Extensive experience with: Animal models • In vivo • Leukocyte migration • Immunohistochemistry • Staining • En face • Immunofluorescence • Cryosectioning • Paraffin • DNA extraction • RNA extraction • PCR • Gene expression • qPCR • TaqMan • Confocal microscopy • Bright field microscopy • Dissection microscopy • Ex vivo • FACS Analysis • FlowJo • Image analysis and Quantification • In vitro assays • Cell culture • Cell transformation • siRNA • Colorimetric assays • GLP • Lab safety • Risk assessment • Scientific writing • Adobe Illustrator • Biostatistics • Literature mining • Cholesterol measurements • Triglycerides measurements • Glucose measurements • SMCs • Macrophages • Vascular Endothelium • Air pouch • Automated laboratory robots • Mouse aortic dissection and pinning • Blood pressure

Cardiovascular Genomics GroupVascular Biology UnitDepartment of Medical Biochemistry and BiophysicsAnimal handling • Genotyping • DNA extraction • PCR • Immunohistology • Confocal imaging • Data quantification and analysis • Literature mining

Department of Immunology, Genetics and Pathology (IGP), Rudbeck Laboratory, UppsalaSupervisor: Masood Kamali-Moghaddam"Detection of gamma-secretase via proximity ligation assays"Proximity ligation assay (PLA) • Solid phase • in situ • Cell culture • Cross-link antibody conjugation • Immunofluorescence • Confocal microscopy • Image analysis and quantification • qPCR • SDS-PAGE • HPLC • Literature mining • Scientific writing • Public oral presentation

Project on plant pathogenic viruses.Plant extracts • ELISA • Spectrophotometry

Physiology Department.Project on sphingolipids and aging.Cell culture • DNA extraction • RNA extraction • qPCR • PAGE • Quantification

Animal Physiology Department, Faculty of Biology.Project on aging, neuro-immunology and nutrition with focus on oxidative stress.Animal handling • Tissue sampling • Tissue processing • Sonication