Arpita Desai
Angestellt, Medical device consultant, ProPharma Group
Leipzig, Deutschland
Über mich
I am an award-winning patent owner with profound experience in establishing Quality management system for medical devices. Driving the innovation from bench to bedside is what I mastered in using my experience of working in research, design and development, validations, manufacturing and ensuring compliance to the standards and regulations. This helps in building essential bridge between the different areas for medical device development and spearhead realisation of innovative ideas.
Werdegang
Berufserfahrung von Arpita Desai
3 Jahre und 4 Monate, Sep. 2018 - Dez. 2021
Head of Quality Management
Bellaseno GmbH
- Trained, qualified and certified Lead auditor, Internal auditor and external supplier auditor – conducting and leading audits internally, externally, including supplier audit - Successfully established Quality management systems for medical devices from scratch and lead team for full EN ISO 13485:2016 certificate - Risk Management as per EN ISO 14971:2019 - Plasma surface modification of 3D printed polymer scaffolds, Packaging and gamma sterilization of scaffolds - CA/PA and process improvements
1 Jahr, Sep. 2017 - Aug. 2018
Manufacturing and QA process engineer
Bellaseno GmbH
- 3D printing of innovative scaffold CAD models and developing stable parameters for the same - Project management of plasma treatment for surface modification - Project management of gamma sterilization of medical devices as per ISO standards - Development of Quality management systems for medical devices - Implementation of ISO 13485:2016 & ISO 14971:2012 for CE Mark and FDA approval of medical implant
1 Jahr und 3 Monate, Aug. 2016 - Okt. 2017
Scientific assistant
Fraunhofer-Institut für Mikrostruktur von Werkstoffen und Systemen IMWS
3 Monate, Mai 2016 - Juli 2016
Working Student
Max Planck Institute for Human Cognitive and Brain Sciences
3 Monate, Juni 2015 - Aug. 2015
Trainee
Siemens Healthineers
3 Monate, Dez. 2014 - Feb. 2015
Engineering Intern
Bhailal Amin General Hospital
Ausbildung von Arpita Desai
1 Jahr und 7 Monate, Okt. 2015 - Apr. 2017
Biomedizinische Technik/ Biomedical Engineering
Martin-Luther-Universität Halle-Wittenberg
3 Jahre und 11 Monate, Juli 2011 - Mai 2015
Biomedical Engineering
Gujarat Technological University
Sprachen
Englisch
Fließend
Deutsch
Grundlagen
Gujarati
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Hindi
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