Ganesh Dinesh

Praktikum, Research Assistant, MD2B LifeScience GmbH
Magdeburg, Germany

Fähigkeiten und Kenntnisse

Project Management
ISO 13485
MS Office
Complaint Handling
CAPA
Altium Designer
Quality Audits
Change Management
Risk Management
Medical Device Regulation (MDR)
21 CFR 803 820
Compliance
FDA
Reliability
Team work
Communication skills
Commitment

Werdegang

Berufserfahrung von Ganesh Dinesh

  • Current 5 months, since Jan 2026

    Research Assistant

    MD2B LifeScience GmbH

  • 2 years and 8 months, Aug 2021 - Mar 2024

    IT Analyst

    Tata Consultancy Services Ltd

    Led a team of 23 analysts in Post-Market Surveillance, ensuring regulatory reporting for EMEA & APAC. Ensured ISO 13485, FDA 21 CFR 803/820, EU-MDR compliance, reducing non-conformance. Optimized processes, cutting costs & enhancing efficiency. Conducted investigations & SOP updates. Delivered Qlik Sense training & TWI documentation for EU operations. Managed PCB/PCBA design updates in Altium, ensuring manufacturing compliance. Drafted RFQs & project proposals for complaint management.

  • 3 years and 7 months, Jan 2018 - Jul 2021

    System Engineer

    Tata Consultancy Services Ltd

    Handled customer complaints while ensuring regulatory compliance. Conducted investigations and prepared FDA regulatory reports. Maintained audit adherence, supporting product release. Provided training on LIPI systems & Phaco devices after professional certification.

Ausbildung von Ganesh Dinesh

  • Current 2 years and 2 months, since Apr 2024

    MEDICAL SYSTEM ENGINEERING

    Otto-von-Guericke University Magdeburg

    Current Grade- 2.4

  • 4 years and 2 months, Jun 2013 - Jul 2017

    MEDICAL ELECTRONICS ENGINEERING

    Visvesvaraya Technological University

    CGPA- 8.29/10.00

Sprachen

  • English

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    B1-B2 (Gute Kenntnisse)

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