Jahnavi Nori – Austin

Jahnavi Nori
Austin, TX

Cell: 973-393-0617
Email: jahnavinori@gmail.com

OBJECTIVE: To perform assigned duties in a resourceful manner, to learn & apply latest
methodologies & strategies while working with the medical devices and to process
vocation opportunities that will utilize my knowledge and skills to influence
organizational growth.

EDUCATION: Master’s in Biomedical Engineering (MS in BME) Focus: Medical Instrumentation
New Jersey Institute of Technology, NJ Graduated: May 2013

TECHNICAL SKILLS:

  • AQS Certified Internal Auditor for Medical Devices ISO 13485, ISO 9001 (E)
    CAPAs, GMP, GLP
  • Regulatory Affairs, Governing Body Knowledge (FDA, ISO, 21 CFR 820)
  • Incident Reporting, FAERS (FDA Adverse Event Reporting System), MDR
  • Complaint Investigations
  • Technical Writer – Audit Reporting, Authoring SOPs, WIs, Document Controls,
    Change Controls.
  • Cross Functional Team Management, Interaction with Global Managers, and
    coordinating Service Teams, Clinical Application Specialists in USA with
    Manufacturers in Switzerland and interacting with Customer base across the
    globe.
  • Acquainted with Product Life Cycles and product development processes such
    as Design Controls, Change Controls for Medical Devices & Project Management
    Processes
  • Familiar with FMEA, Risk Management
  • Presentation Skills, Adobe Acrobat Pro DC (can create fillable forms using
    JavaScript logic in the PDF background)
  • Leadership, networking/team building, Adaptability to Stress

EXPERIENCE:
August 19th 2013 to April 20th 2017:

KARL STORZ Lithotripsy America Inc. (KSLA)
Last Position Held: Internal Quality Auditor/Quality Engineer

Responsibilities in Last Position Held:
Internal Quality Auditor/ Quality Engineer:

  • Regarded as a subject matter expert in Regulatory Affairs and Quality Audits.
  • AQS Certified Internal Quality Auditor for Medical Devices (ISO 13485, ISO
    9001.E). Excellent track record in delivering exceptional results on assigned
    Internal Audits.
  • Participated in FDA Audits and Inter Corporate Audits
  • Authored, reviewed and approved new product documentation and applied
    change controls to make changes to existing documents.
  • Regulatory Affairs professional with 3+ years of experience on regulations set
    forth by the governing bodies (FDA), and applying the knowledge attained
    towards business practices to provide regulatory input, guidance and advice
    to Service teams in the USA and design teams in Switzerland.
  • Manage Quality Systems and Quality Documentation.
  • Extensive knowledge in QAQC, CAPAs, Incident Reporting, MDRs, FAERS (FDA
    Adverse Event Reporting System), Good Manufacturing, Clinical and Lab
    Practices, Complaint Handling, Investigations, non-conforming product and
    part assessments.
  • Implementation of CAPA, correction of NCs.
  • Cross functional skills in reporting the incidents to the Global Quality Manager
    at the Corporate Headquarters located in California and to the manufacturer
    located in Switzerland.
  • Audit incoming parts, shipments from various suppliers to ensure correct
    labeling and no damage, and test for conformity.
  • Conduct Quarterly Quality Meetings with all the Departments: Service,
    Logistics, Sales, Clinical Applications here in the USA and coordinating with
    the Product Development Team, Design & Manufacturing at Switzerland in
    learning and relaying the new and pertinent information to my colleagues,
    explaining the need for Regulations and the need to bring about changes or
    additions to our company Standards to stay within compliance and be ever
    ready for surprise Audits from the governing bodies.
  • Familiar with the Verification & Validation processes.

Technical Writer:

Author and/or revise regulatory policies & Standard Operating Procedures for
our products to maintain up-to-date documents with constantly evolving FDA
regulations & compliance environment. Technical writing involves
writing/revising and maintaining the Quality Manual as well.

Responsibilities in Previous Positions:
Field Support Engineer and In-house Engineer:

  • Provide Technical Support to our large customer base by traveling to
    various Customer sites, in United States to troubleshoot and fix problems
    on the product and provide On-the-site training to Customers (Litho
    Technicians/Doctors) about the system specifics and operation.
  • Pre-Installing lithotripters, performing Preventive Maintenance and
    staging the equipment before distribution from KSLA.
  • Development of necessary documentation for new products.
  • Maintenance of Demo Equipment at KSLA and associated documentation.
  • Re-conditioning lithotripters when necessary.
  • Learn new methods and techniques during bio-medical training at
    Switzerland Headquarters to gain expertise and support Storz Medical AG
    Equipment.
  • Providing (24X7) support to the customer base as well as Karl Storz Field
    Engineers.
  • Identify the need, design and develop parts as necessary. Help in
    identifying parts and place orders as necessary.

Test Equipment Calibration Manager:

Logistics:

  • Served as Calibration Manager & regarded as a specialist for maintaining
    Test Equipment Calibrations within FDA requirements. Worked on
    various test devices such as the Multimeters, HV Probes, Dosimeters, Electrical Safety Analyzers, Torque Wrenches, Fluoro Test Phantoms, X-Ray Maintenance Kits, etc.
  • Maintaining the current Calibration certificates safely in the Document Control Room.
  • Track record of maintaining up-to-date calibrations on all test equipment with zero discrepancies.
  • FDA auditors and Inter-Corporate auditors have commended my work for the neat maintenance and timely updates of the Calibration website with latest and appropriate information and for keeping track of the due dates via Automated Emails to Field Service Engineers and sending personalized emails if the due dates have passed.
  • Contacting Calibration Companies for annual Quotes & working out a budget that is beneficial for the organization. Choosing wisely from the various approved vendors available. Creating blanket Purchase Orders (P.O) for all Test Devices on a single P.O.
  • Can identify parts and assemblies in KSLA Inventory and perform Logistics required to process a Sales Order or Field Service Engineer (FSE) Order and assist with packing and shipping parts.

SAP End User Knowledge:

  • Functional knowledge in Material Management (MM) and (SD)
    Sales & Distribution Modules in SAP-ERP Software; over legacy
    systems.
  • Can execute SAP (MM and SD) Business Transactions by Creating Orders to
    Procure Materials (MM03) using SAP Software – by picking parts, entering
    serial numbers, delivering Sales Orders (VL01) or FSE Orders (VL02),
    Creating Purchase Orders, Invoices and reporting these transactions to
    Accounting Department. This process involves integrating all business
    models at KSLA.
  • Familiar with SAP-HANA (CRM) Model. Involved in the blue print phase of
    the project, interacting with SAP Consultants to explain our business
    structure and our needs.

Summer 2012: Siemens Ltd.
Position: Intern

  • Took training on X-ray Technology, Ultrasound, Fluoroscopy, C-Arms,
    Lithotripters, CT and MR
  • Acquainted with Siemens Product Technologies and market strategies.
  • Assisted application specialists in equipment & software installations and
    presenting latest product information to doctors and technicians in
    hospitals.
  • Helped in maintaining and repairing medical equipment per Siemens
    Standard procedures.
  • Assisted senior technicians in testing and calibrating equipment.
  • Promoted Siemens products and services through product
    demonstrations and factory visits.
  • Coordinated with doctors & hospital in charges to ensure all requirements
    regarding equipment are met per Siemens policies.

Summer 2009: Global Hospitals Group
Position: Intern

  • Trained on basic troubleshooting of medical equipment used in hospitals
  • Posted to various departments for training such as Cardiology, Nephrology,
    Radiology, OTs, Bio-Chemistry Labs and Blood Banks for basic trouble
    shooting of medical equipment.
  • Visited Indo-American Cancer Institute and gained insight on chemotherapy,
    radiotherapy and brachytherapy procedures.
  • Assisted the Biomedical HOD in performing equipment/machinery inventory
    and logistics.
  • Helped in documentation and maintaining records

PROJECTS:
May 2013:

Masters Capstone: Virtual Instrumentation Project, NJIT

  • Conceptualized and designed a logical software program for ECG R-Wave
    Detection and EMG Onset & Offset detection in Muscle Contraction using
    Virtual Instrumentation Software. (LabVIEW version 2012)

Jan 2013:

  • Engineered Designs of parts & assemblies, 3D printed them using CAD ProE 5.0

May 2010:

Undergraduate Capstone Design Project, BVRIT

  • Designed a Portable Microcontroller based Tremor Analysis Device for
    Parkinson’s disease Patients
  • The device was made using motion sensors, microcontrollers & ADC/DAC
    Systems
  • Device was developed & delivered to assist Doctors, Neurologists in
    analyzing tremors in patients.
  • Statistics were obtained from Parkinson’s Patients versus normal people in
    Nizam’s Institute of Medical Sciences & Hospital Firm, Hyderabad

HONORS/AWARDS/ACHIEVEMENTS:

  • Much admired for exceptional performance in providing extraordinary
    outcomes on assignments entrusted; especially with regards to Quality
    Systems, Audits & Regulatory related work.
  • Excellent track record for building Customer Relationships and for receiving
    commendable feedback on multiple occasions from different customers.
  • Proven track record of successful field trips. Not a single unsuccessful trip till
    date in the entire tenure at KSLA. Known for handling complex problems on
    the machine out on the field independently
  • Academic Excellence Award – JNTU (University in Hyderabad, India)
  • Ranked 9th among 1000 students
  • Meritorious Student Award– BVRIT Alumni Association
  • Bio-Medical Engineering Department Topper

VOLUNTEER EXPERIENCE:

  • Active Member in Non-Profit Organizations
  • Active Member of Spoorthi Foundation (A Home for homeless) in Cherlapally,
    Hyderabad

STRENGTHS:

Problem solving abilities, creative writing, communication & presentation
skills, leadership capabilities, capability to deal with complex and stressful
situations

REFERENCES:

Available upon request

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