Ing. Somashekara Koushik Ayalasomayajula
Angestellt, Senior Associate, Medidee Services (Deutschland) GmbH
Munich, Deutschland
Über mich
Certified Auditor for Medical devices (ASQ CMDA) and QA/RA professional supporting MedTech stakeholders in achieving compliance with global requirements. Experienced in medical device product development, risk management, human factors, V&V and Quality & Regulatory planning and project management. Regulatory markets: EU, MDSAP (Australia, Canada, Brazil, Japan & US), South Korea, Argentina, South Africa, India, ASEAN My skillset includes: - EU 2017/745 (MDR) and 93/42/EEC (MDD) - MDSAP - FDA 510k & PMA - QMS (Quality Management Systems) implementation (ISO 13485) - Risk management (ISO 14971) - Design controls (21 CFR 820.30) and CAPA (21 CFR 820.100) - Trained auditor for ISO 9001, ISO 13485, MDSAP - Medical Device Software Lifecycle Management (IEC 62304 and 82304) - Usability/ Human Factor engineering (IEC 62366) - Medical device testing - Product development - Process optimization - CAD & Simulation (Pro-E, CATIA, Solidworks) - Six Sigma & Lean methodologies
Werdegang
Berufserfahrung von Somashekara Koushik Ayalasomayajula
Bis heute 3 Jahre und 2 Monate, seit Apr. 2021
Line Manager
Medidee Services (Deutschland) GmbH
Bis heute 4 Jahre und 2 Monate, seit Apr. 2020
Senior Associate
Medidee Services (Deutschland) GmbH
- Pre-Submission review of technical documentation to Notified Bodies for medical devices and ancillary therapeutic and /or diagnostic products - Deployment, documentation and maintenance of QMS acc. to ISO 13485, MDR and MDSAP requirements for clients - Development of risk management strategies, procedures and files - Execution of regulatory compliance audits for clients - Training of employees in relevant QMS and technical standards - Team management
1 Jahr und 8 Monate, Aug. 2018 - März 2020
Project Associate
Medidee Services (Deutschland) GmbH
- Pre-Submission review of technical documentation to Notified Bodies for medical devices and ancillary therapeutic and /or diagnostic products - Development, documentation and implementation of QMS and related support activities for clients - Development and document regulatory files for medical devices and ancillary products - Development of risk management strategies, procedures and files - Implementation and validation of processes - Execution of regulatory compliance audits for clients
11 Monate, Apr. 2017 - Feb. 2018
Werkstudent
B. Braun Avitum Saxonia GmbH
Assistance in technical documentation. Investigation of new materials for primary packaging of medical devices. Process optimization of hollow fiber spinning
9 Monate, Juli 2016 - März 2017
Master thesis
B Braun Avitum Saxonia GmbH
Ageing of Ultra filtration membranes. Understanding the effects of various parameters on ageing behavior of hollow fiber ultra filtration membranes and Validating the technique of accelerated ageing to investigate the shelf life of a haemodialyzer.
3 Monate, Apr. 2016 - Juni 2016
Praktikant
B Braun Avitum Saxonia GmbH
Modeling of hemodialysis: Understanding urea kinetics and building a numerical model for 1 and 2 compartment hemodialysis system with the aid of MATLAB. Verification of developed model with standard models available.
2 Monate, Juni 2013 - Juli 2013
Project Trainee
BHEL
Understanding the basic designing of steam turbine, diagrammatic representation of the velocity triangles and knowing in detail about the various parts of steam turbine. Fabricating various parts of steam turbines using various machines and processes involved followed by assembly of parts and then balancing of forces acting on the rotor of the steam turbine.
2 Monate, Juni 2012 - Juli 2012
Trainee
Central Institute of Tool Design
- Creation and review of drawings - Write CNC codes to facilitate the production of components - Service and maintenance of production machines
Ausbildung von Somashekara Koushik Ayalasomayajula
3 Jahre, März 2015 - Feb. 2018
Polymer Technology
Hochschule Aalen
Specialised in 'Applications of Polymers in Health Care and MedTech Sector' Subjects: Polymer Materials, Polymer testing, Polymer physics & Rheology, Injection Molding, Extrusion, Design Of Experiments (DOE), Mold design, Control Engineering and Process Simulation
4 Jahre und 1 Monat, Aug. 2010 - Aug. 2014
Mechanical Engineering
Lovely Professional University
Focus on Product Development, Material sciences and Quality Engineering.
Sprachen
Englisch
Muttersprache
Deutsch
Gut
Hindi
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Telugu
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