Lilian Hren
About Lilian Hren
Lilian Hren is a QA Engineer with over 10 years of experience in the medical device industry, specializing in regulatory affairs and quality assurance. She currently works at Fluke Corporation and has held various positions in Brazil, France, and Portugal, holding multiple certifications in quality standards.
Work at Fluke Corporation
Lilian Hren has been employed at Fluke Corporation as a QA Engineer since 2018. In this role, she applies her extensive knowledge in quality assurance and regulatory affairs within the medical device industry. Her responsibilities include ensuring compliance with various quality standards and regulatory requirements, contributing to the overall quality management system at Fluke.
Professional Experience in the Medical Device Industry
Lilian Hren has over 10 years of experience in the medical device industry, focusing on regulatory affairs and quality assurance. She has held positions at several organizations, including Víncula from 2009 to 2015, AMPLITUDE SAS from 2015 to 2017, OBL Dental from 2016 to 2017, and Astrolabe Medical from 2017 to 2018. This diverse experience spans multiple countries, including Brazil, France, and Portugal.
Education and Certifications
Lilian Hren studied Production Engineering at Uninter and holds a Bachelor's degree in Education from UFSCar - Universidade Federal de São Carlos. She has obtained several certifications relevant to her field, including GMP, ISO 9001, ISO 13485, and ISO 17025 standards. Additionally, she is certified as an ASQ-CQA (American Society for Quality - Certified Quality Auditor).
Regulatory Expertise
Lilian Hren possesses expertise in navigating regulatory requirements for medical devices. She is knowledgeable about compliance with agencies such as ANVISA, CE, FDA, INMETRO, TUV, COFEPRIS, NVLAP, DOELAP, CNSC, and A2LA. Her experience includes working with quality systems for Class I, II, and III medical devices, ensuring that products meet stringent regulatory standards.