Ana Aguilar

Mdr Quality Assurance Engineer Iii @Merit Medical Systems, Inc.

Tijuana, MX

Develops Design failure mode and effect analysis (DFMEA) and Process failure mode and effects analysis (PFMEA) for submission of different medical devices for MDR certification for European regulation. Develops Quality risk management Table is a crucial process for ensuring the safety and efficacy of medical devices throughout their lifecycle, from development to commercial manufacturing. By proactively identifying and managing potential risks, manufacturers can minimize the chances of quality issues arising and ensure that the final product is of high quality and safe for patients to use. Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e, 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 20) and other applicable standards. Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21 CFR 820. Review and approve project documents to ensure adequate coverage for the project\'s defined scope. Knowledge of cGMP, FDA/EMA regulations. Support regulatory inspections by FDA and foreign regulatory agencies. Responsible for creating the Post-Market Surveillance Plan (PMSP), Post-Market Surveillance Report (PMSR), Canadian Summary Reports (CSR), Periodic Safety Update Report (PSUR)Data Collection and Risk Review, and Periodic Safety Update Report for medical devices on an annual basis.

Universidad Tecnológica de Tijuana

Engineering Technican , Polymer/Plastics Engineering

Instituto Politécnico Nacional

Professional English Certification , English

Universidad Autónoma de Baja California

Engineer's degree, Industrial Engineering