Yashaswini Patwardhan
Angestellt, Senior Associate, NSF International
Karlsruhe, Deutschland
Werdegang
Berufserfahrung von Yashaswini Patwardhan
Bis heute 7 Jahre, seit Juli 2017
Senior Associate
NSF International
Client is located in the Munich area and is a medical device manufacturer. Project involves creation of Summary technical file documentation (STED) for numerous products related to dialysis treatment including dialysis machines, haemodialysis concentrates and tubing sets. Creation of a MDR compliant STED for a class III sterile priming solution. Assessment of infusion pump system technical files for EU MDR compliance and propose remediation plan to address gaps for a client located in San Diego CA.
1 Jahr und 11 Monate, Sep. 2015 - Juli 2017
Senior Associate
NSF Avarent: A NSF Health Sciences Company
Provide consulting services for QMS remediation in the areas of post market surveillance (CAPA's, complaint handling, MDR reporting) for a client company manufacturing heart lung machines and other on-pump cardiac surgery devices. Subject Matter Expert services on risk management process improvements for a client company manufacturing auto injector devices.
1 Jahr und 8 Monate, Feb. 2014 - Sep. 2015
Senior Associate
Avarent LLC.
1 Jahr und 9 Monate, Juni 2012 - Feb. 2014
Principal Engineer, Risk Management
Baxter in den USA
Lead quality engineer on the risk management team responsible for creation, update and maintenance of the risk management file and risk management process. Risk management and quality engineering representative on a team leading changes to design based on usability study results.
2011 - 2012
Sr. Risk Management Engineer
Sigma International General Medical Apparatus, LLC.
Ausbildung von Yashaswini Patwardhan
2003 - 2005
Biomedical Engineering
University of Southern California
Sprachen
Englisch
Fließend
Deutsch
Fließend
Marathi
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Hindi
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