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Ing. Somashekara Koushik Ayalasomayajula

is working from home. 🏡

Angestellt, Director, Quality & Regulatory Affairs, Veranex Germany GmbH
Cottbus, Deutschland

Fähigkeiten und Kenntnisse

MDD / MDR
ISO 13485
MDSAP
Medizintechnik
Kunststofftechnik
Six Sigma Green Belt
21 CFR 820
Regulatory Affairs
CAPA
ISO 11135
ISO 11137
ISO 14971
FDA Regulation
hollow fibers
Mold Flow Analysis
MatLab
Simulink
Minitab
Plastic injection moulding
T-sim
Ansys
AutoCAD
Design of Experiment DOE
MS Office
MS Project
Lotus Notes
Dialysis
Packaging Technology
Extrusion
Polymers
Mechanical Engineering
Forschung und entwicklung
English Language
Spritzgusstechnik
Kunststoff
Prüfung
Materialwissenschaft
Produktentwicklung
Projektmanagement
Change management
Documentation
Engineer
Medical device
Management
Compliance
Audit
Consulting
Quality Management
QMS
Team work
International experience
Communication skills
Team Management
Flexibility
independent
Leadership

Werdegang

Berufserfahrung von Somashekara Koushik Ayalasomayajula

  • Bis heute 1 Jahr und 8 Monate, seit Okt. 2023

    Director, Quality & Regulatory Affairs

    Veranex Germany GmbH

  • 9 Monate, Jan. 2023 - Sep. 2023

    Senior Consultant

    Medidee Services (Deutschland) GmbH

  • 2 Jahre und 9 Monate, Apr. 2020 - Dez. 2022

    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

    Fließend

  • Deutsch

    Gut

  • Hindi

    Muttersprache

  • Telugu

    Muttersprache

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