Dr. Florin Iuliu Trifa has a diverse range of work experience spanning multiple industries. Their current role is as the Head of Quality, Regulatory, and Clinical Affairs at Z-SYSTEMS Ceramic Dental Implants since March 2021. Prior to this, they worked at Vyaire Medical from March 2019 to February 2021 as a Senior Manager, where they were responsible for Risk Management, Post Market Surveillance (PMS), and Quality Assurance (QA). Additionally, they also served as the Team Manager and Management Representative at Vyaire Medical.
Before their time at Vyaire Medical, Dr. Trifa worked at BIOTRONIK from May 2015 to February 2019, where they held multiple roles including Risk Manager, Senior Design Assurance Engineer, and Design Assurance Engineer. Dr. Florin Iuliu then moved on to Oerlikon from July 2011 to May 2015, where they worked as a Project Manager, overseeing various customer projects in the field of contract manufacturing for thermal sprayed coatings.
Prior to Oerlikon, Dr. Trifa was employed by Zimmer from December 2008 to June 2011 as a Process Engineer. Dr. Florin Iuliu was involved in project management and implementation of new equipment and processes, as well as holding the position of Green Belt in Lean Sigma. Preceding their time at Zimmer, they worked as a Process Engineer Coating at Alstom Power from November 2005 to November 2008, focusing on surveying and improving the coating process.
Dr. Trifa began their career as a Teaching Assistant at UTBM from September 2003 to August 2005. Dr. Florin Iuliu then transitioned to the automotive industry, working at Dacia from November 2000 to December 2001 as the Purchasing Project Manager Powertrain. Dr. Florin Iuliu was responsible for managing a purchasing budget of over $6 million per year. Before this, they served as the General Manager Assistant (R&D Engineer) at Dacia from 1998 to 2000. In this role, they were responsible for R&D in the field of welding, including optimization of welding procedures, metallurgical analysis, training personnel, and improving the quality level of welds.
Overall, Dr. Florin Iuliu Trifa brings extensive experience in quality assurance, risk management, project management, and process improvement across various industries.
Dr. Florin Iuliu TRIFA has a diverse education history, with a focus on various aspects of the medical device industry. In 1997, they obtained a Master of Science degree in Mechanical Engineering from the University POLITEHNICA of Bucharest. Subsequently, they pursued a Master of Business Administration (MBA) in Marketing Management at the same university in 2000.
Dr. TRIFA continued to expand their knowledge and skills through several specialized training programs. In 2009, they received training in Equipment Qualification in the Pharma Industry from VDI Württembergischer Ingenieurverein / VDI Fortbildungszentrum, and in Medical Devices Quality Management and Regulatory Affairs from TÜV SÜD Akademie. Additionally, they completed a program in Project Management offered by Kepner Tregoe.
In 2012, Dr. TRIFA obtained a Green Belt certification in Lean Six Sigma from Steinbeis Hochschule. This was followed by a training course on Medical Devices: Quality Management Requirements at TÃœV SÃœD Akademie in 2015. Dr. Florin Iuliu also completed a course on Communication at BWI Management Weiterbildung in Zurich in 2017.
Dr. TRIFA's education includes several programs specifically related to the medical device industry. Dr. Florin Iuliu completed a course on Data Integrity in the GMP-environment at Concept Heidelberg in 2017. In 2018, they underwent training on Risk Management for Medical Devices at SAQ-Qualicon AG and also received a certification as a Lead Auditor for ISO 13485:2016 from BSI Training Academy. Furthermore, they attended courses on Change from the MDD to EU MDR 2017/745 and Risk Management of Medical Devices, both offered by BSI Training Academy in 2018.
In recent years, Dr. TRIFA participated in various training programs focused on the new European Medical Device Regulation. These include non-technical training for MDR Eudamed provided by Eudamed in 2020, as well as a course on ISO 14971:2019 Risk Management for Medical Devices: Requirements Training Course offered by BSI Training Academy.
Most recently, in 2021, Dr. TRIFA completed a training program on Good Clinical Practice (GCP) in Switzerland, specifically in the area of research ethics evaluation, through Training and Resources in Research Ethics Evaluation (TRREE).
Overall, Dr. Florin Iuliu TRIFA has pursued a wide range of education and training opportunities to enhance their expertise in various aspects of the medical device industry, emphasizing quality management, risk management, regulatory affairs, and research ethics evaluation.
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