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
EDUCATION: Master’s in Biomedical Engineering (MS in BME) Focus: Medical Instrumentation
New Jersey Institute of Technology, NJ Graduated: May 2013
- 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,
- 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
- Acquainted with Product Life Cycles and product development processes such
as Design Controls, Change Controls for Medical Devices & Project Management
- Familiar with FMEA, Risk Management
- Presentation Skills, Adobe Acrobat Pro DC (can create fillable forms using
- Leadership, networking/team building, Adaptability to Stress
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
- 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
- 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.
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
- Providing (24X7) support to the customer base as well as Karl Storz Field
- Identify the need, design and develop parts as necessary. Help in
identifying parts and place orders as necessary.
Test Equipment Calibration Manager:
- 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
- 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.
- 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
- Helped in maintaining and repairing medical equipment per Siemens
- 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
- 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
- Helped in documentation and maintaining records
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)
- Engineered Designs of parts & assemblies, 3D printed them using CAD ProE 5.0
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
- 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
- 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
- Active Member in Non-Profit Organizations
- Active Member of Spoorthi Foundation (A Home for homeless) in Cherlapally,
Problem solving abilities, creative writing, communication & presentation
skills, leadership capabilities, capability to deal with complex and stressful
Available upon request