Ravi Kanikanti

612-385-3744 (Mobile)

kanikanti@yahoo.com

 

Skills Summary: 

·         10+ years of diverse experience in Information Technology with emphasis in Quality Engineering, Software Quality, Equipment Validation, Cleaning Validation, Computer Systems Validation, Technical Documentation (IQ/OQ/PQ) and Technical Writing skills.

·         Experience in reviewing the Tool Qualification reports, as well as review of process validation protocols, qualification protocols, and technology transfer documents.

·         Experience as Validation Engineer in authoring documentation for computer systems, and equipments to comply with 21 CFR Part 11 and 21 CFR Part 820.

·         Working knowledge of ISO 9000 and ISO 13485

·         Working knowledge of IEC 60601-1 3rd Edition Standard for medical electrical equipment.

·         Experience in designing test plans, defining test cases, developing and maintaining test scripts, and analyzing bugs.

·         Experience working with OEMs and their customers.

·         Experience in Statistical Analysis and Data Interpretation.

·         Excellent written and verbal communication skills.

·         Excellent organizational skills, capable of multi-tasking.

 

Work Experience:

 

Sep 2012 to Present 

Sr. Software Quality Engineer - Terumo Cardiovascular Systems

 

·         In charge of remediation, Process and Software Validation documents, review and adhering to company SOPs and Work Instructions.

·         Reviewing, preparation and Signing of CAF, IU, FRS, SDS, EQs, TMVs and IQ, OQ, PQ, TM, and VSR.

·         Worked to have the consent decree removed from company.

·         Perform duties as Senior Software and Process Quality Assurance Engineer.

·         Work with response team to Consent Decree audit review.

·         Involved with Quality Audits and worked with Management to update the SOPs.

·         Worked on all FDA and Regulatory comments in order to bring system up to acceptable standards.

·         In charge of writing the first draft of the URS for the JD Edwards ERP system and reviewing protocols for SQAE approvals.

·         Involved in writing and reviewing the Risk analysis, Process Flow diagrams, Manufacturing Work Instructions & PFMEA documents.

 

             

Feb 2012 to Sep2012 – Beckman coulter

Quality Systems – Sr. SW Quality Engineer

 

·         Review and Approve Batch Production and Control Records to ensure they comply with all established procedures before a batch of drugs can be released.

·         Review the completed batch production and laboratory control records for critical process steps for GMP and ensures that all blanks are filled comments completed properly, and all signatures and dates are in order.

·         Responsible for label, labeling and specimen control. Verifying signatures, checking the chronological order of events.

·         Verifying calculations and numerical data, determining GDP clarity and proper referencing of written comments.

·         Ensuring data entry, results are within specifications.

·         Extensively reviewed the executed Batch Records to identify discrepancies, deviations, or interventions that have occurred during the manufacturing and closed them.

·         Worked on CAPA (Corrective Action/Preventative Action).

·         Conduced Root Cause Analysis.

·         Make recommendations and influence the adoption of best practices related to validation.

·         Assist in the creation and update of processes and procedures.

·         Ensure that critical issues, technical considerations, and risk is addressed.

·         Provide expert input into requirements definition, functional specifications, designs, and other project deliverables.

·         Ensure not only compliance, but thorough and efficient systems addressing business needs.

 

July 2011 to Feb 2012 - Medtronic

Sr. Quality Engineer

·         Writing the POS (Proof Of Stations)

·         Executing the POSs

·         Making sure all the processes are correct and quality compliance.

·         Creating reviewing and Approving the Workflows/Change Requests

·         Working in Universal Burnin Test Systems (UBITS) project.

·         Writing the Software Validation deliverables for the following:

Equipment Specifications, Software Design, Software Requirement Specifications, SIQ, SVP, IQ, OQ & PQ

·         Writing the Requirement Trace Matrix and Summary reports

·         Executing the Validation deliverables, reviewing and Approving

 

 

April 2011 to July – Zimmer Surgical

Sr. Quality Engineer

·         Working in Non‐Sterile Soft Goods Production Transfer Project.

·         Writing software validation documents like IQ, OQ and PQs.

·         Writing the Requirement Trace Matrix and Summary reports

·         Equipment/ Fixtures, Equipment Listing, Equipment Calibration Review.

·         Gauge List, Gauge Calibration Review

·         Review History of Product for Prior 6 months, Product Complaint Data

·         Review In‐process QA Procedures

·         Develop Boundary Samples for Supplier

·         Pre‐release Product Review

·         Transition of Sourcing Quality Plan

·         Develop all of the inputs for the Transfer FMEA

·         Extensively used oracle datbase.

·         Intensified Finished Goods Inspection at Distribution Center

·         Testing of ATS 2000 Pneumatic Tourniquet, intended use is to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities (IEC 60601)             

 

 

Jan 2011 to April - Boston Scientific - Maple Grove, MN

Sr. Software Quality Engineer 

·         Serves as a Software Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site divisional and corporate quality goals and priorities.

·         Ensure conformance to SOPs, Work Instructions, Templates, and Forms pertaining to Manufacturing/Production equipment.

·         Create software verification and validation test plans and reports.                           

·         Promote a structured software development process.

·         Providing oversight for all software validation development, planning deliveries and creating test documents.

·         Writing the Software Validation deliverables such as PM, QPW, EDS, ES, IQP, OQP, PQP and QSR.

·         Writing Requirement Trace Matrix.

·         Manage Validation engineers & technicians in test execution.

·         Review, provide feedback and approve on all the Change Notices assigned activities.

·         Work closely and conduct meetings with cross functional teams

·         Looking after Oracle database.

 

Dec 2009 –   St. Jude Medical – Minnetonka, MN

Dec 2010          Sr. Quality Engineer

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.

·         Authored Validation deliverables such as PM, QPW, EDS, ES, IQP, OQP, PQP and QSR.

·         Work specifically with Legacy equipment protocols and compliance with 21CFR part 11

·         Executed Validation protocols such as IQP, OQP and PQP.

·         Software testing execution of PC based Embedded software.

·         Extensively used the Mini Tab for Cpk and Gauge R&R

·         Got full Training on Windchill, Submitted Change Requests (CR) to Change control board and handled Change Requests

·         Verified that all activities are in compliance with GMP and FDA requirements

·         Reviewing and signing the Validation Deliverables such as PM, QPW, ES, IQP, OQP and PQP.

·         Reviewing and signing the EDS & QSR.

·         Worked extensively on tooling inspection and Fixtures.

 

Nov 2008 -      Zimmer (Dover OHIO) (Consultant with Experts, Inc.)

Dec 2009         Sr. Quality Engineer 

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related orthopaedic surgical products.  Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries.  Zimmer’s 2007 sales were approximately $3.9 billion.  The Company is supported by the efforts of approximately 8,500 employees worldwide.

Responsible for reviewing design drawings for tolerance, inspect-ability and quality of design issues

 

·         Review of process validation protocols, System Specifications, Qualification Protocols, and technology transfer documents.

·         Highly experienced in areas including preparation of standard operating procedures for setup, operation, and cleaning of manufacturing equipment

·         Responsible for performing design reviews and pre-validation assessments

·         Review Department Procedure against Genesis programs to verify if any inspection criteria are missing.

·         Verify all devices manufactured in the Dept. are covered by Dept. Procedures.

·         ZSINC Review _Verify critical dimensions on Print match the dimensions to be inspected on ZSINC

·         Reviewing and signing the Zimmer OSP Master Setup Sheets for Extrusion lines.

·         Reviewing and signing the Zimmer OSP Master Setup Sheets for Injection Molding lines.

·         Reviewing and qualifying the Tool Qualification Approval Form Base Cpk sheets for Extrusion and Molding

·         Extensively worked on Gauge R&R

·         Extensively used the Mini Tab for Cpk and Gauge R&R

·         Extensively working in building the QAIFs for Molding and extrusion prints – QA-In-Process Inspection Form

·         Creating the QA897 Binders for Extrusion, Molding and Inside Packaging – Quality Review Checklist-  which has got 5 sheets with GENESIS, ZSINC, QA Test Procedures, Departmental Procedures, Calibration records

·         Incoming and receiving raw materials, sampling raw materials, shipping finished goods, warehouse operation, calibration of equipment.

·         Reviewing and updating the Bill Of Materials ZSINCS and Device Drawings.

·         QA/QC processes, sampling systems, procedures and statistical techniques.

·         Extensively involved in testing the surgical equipments.

·         Extensively involved in testing electrical medical equipments (Automatic Tourniquet Machine). IEC 60601 Standard

·         Extensively involved in creating the Change Notices.

·         Supporting customer complaint investigations and reporting.

·         Extensively used Track wise to manage quality and compliance issues and to ensuring that all the required data is logged and reported.

·         Worked on CAPA (Corrective Action/Preventative Action).

·         Analyzes reports, returned products, recommends corrective action and Notification of  Defects

·         Extensively involved with Manufacturing, incoming, purchasing and calibration departments.

 

Mar. 2008 -               Experts, Inc.                                                                                                               

Nov 2008              Quality Engineer

                            Teleflex Medical, RTP, NC

Teleflex Medical, Mexico

Teleflex Medical, a division of Teleflex Incorporated, is a global supplier of medical devices, surgical instruments, and disposable medical products.                                                                      

 

·         Quality Engineer assigned to the Teleflex, Mexico facility.

·         Perform Compliance Gap Analysis.

·         Qualified all the Process Equipment in the plant.

·         Involved with scoping and identifying high priority requirement for implementation.

·         Translated business requirements and user needs into functional specifications.

·         Reviewed and signed the Validation Deliverables such as IQP, OQP and PQP.

·         Reviewed and signed the Test Summary Reports.

·         Developed and executed risk analysis and validation activities using FMEA.

·         Responsible for conducting Factory Acceptance Test (FAT).

·         Extensively involved in developing manufacturing process validation requirement and Traceability Matrix.

·         Submitted Change Requests (CR) to Change control board and handled Change Requests after approval.

·         Reviewed and approved CRs, deviation reports and rework procedures.

·         Verified that all activities are in compliance with GMP and FDA requirements.

·         Involved in CAPA.

·         Assured product quality is in compliance with GMP Manufacturing.

·         Process Problem Resolution - Assisted in identifying the process improvements and the development of a series of experiments to verify process improvements.

                                                                                                                                           

Oct. 2005 -                Lunina Engineering, Inc.

Mar. 2008              Quality Engineer

                            Boston Scientific - Maple Grove, MN

Leading manufacturer of Stents and Catheters used in Angiograms and Cardiovascular surgeries. APEX is an automated manufacturing program implementing software guided Electromechanical manufacturing systems with PLCs.

As a Senior Validation Engineer.

 

·         Authored Validation deliverables such as URS, FS, IQP, OQP and PQP.

·         Executed Validation protocols such as IQP, OQP and PQP.

·         Developed Requirement Traceability Matrix.

·         Performed Compliance Gap Analysis.

·         Conduced Root Cause Analysis.

·         Placed documentation under Change Control.

·         Reported to project lead on progress and status of validation efforts.

·         Quality Approver - Reviewed all documentation.

·         Work cross-functionally with Quality, Manufacturing, and Process Development to develop and resolve quality issues arising out of validations.

·         Worked with Calibration Department for the calibration certification of the equipment.

·         Worked with external vendor equipment.

·         Worked with OEMs and their customers.

·         Responsible for the Equipment Safety Reports.

 

Apr. 2005 -              Medtronic Inc - Minneapolis, MN                           

Oct. 2005              Validation Engineer

 

·         Responsible for the design, implementation, and maintenance of comprehensive test plans

·         Design and review the test scripts using the system requirement documentation

·         Developed the test scripts using Tcl/Tk and C++

·         Reviewed the design and coding of the test scripts

·         Automate the test scripts using the Automated test CFT tool

·         Perform unit, system and regression tests of all software releases

·         Authored Validation deliverables such as IQP, OQP and PQP

·         Executed Validation protocols such as IQP, OQP and PQP.

·         Reported bugs found during testing using PVCS Tracker

·         Development and testing of the class 111 Cardiac defibrillators using IEC 60601

standards.

·         Extensively used the backend database Oracle.

 

Feb. 2004 -               Kinetic Solutions, Inc.

Apr. 2005              Senior Quality Assurance Engineer

Wells Fargo - Minneapolis, MN

 

·         Authored project test plan and summary report.

·         Performed queries on databases and perform data validation.

·         Authored and implemented standards and procedures for QA department.

·         Created Test Case Templates and wrote all the Test Cases based on the Use Cases and designed specifications obtained from the Integration Manager.                                                       

·         Executed all test cases via Soapscope Tool and Saved the Workspaces for Regression Testing.

·         Reported Bugs found during testing using the Bugzilla defect tracking tool.                           

·         Involved in System testing and performed extensive (IAT) Integrated Application Testing and (ET) Enterprise Testing on the latest release

·         Extensively involved in status meetings discussing and resolving technical problems 

·         Had permissions to access CSS Database (millions of real Data)

·         Conduct middleware testing of policy-based authentication and authorization rules and SSO capabilities to web and enterprise applications with the Netegrity SiteMinder test tool

·         Perform UI testing of all websites including logoff functionality, URI redirects, inactivity timeouts and overall security

·         Execute all test cases via running scripts and saving them to output files. Includes recording and running new scripts and running regression scripts where applicable

·         Set up and maintain test ids for all QA initiatives via GUI applications for customers on the intranet/internal websites and/or in LDAP via running scripts or working directly in iPlanet for customers on the internet/external websites

·         Responsible for writing and implementing standards and procedures for Channel Secure QA department

·         Responsible for maintaining project prioritization plans and reviewing them on a weekly basis

·         Responsible for participating in testing code migrations and server upgrades, installs changes

 

Dec. 2003 -               Robert Half Technology

Feb. 2004              Software Quality Analyst

                            Capella Education Company - Minneapolis, MN

 

·         Analyzed, reviewed and developed software requirements, specification documents and Test Plan.

·         Executed detailed test cases with clear steps and expected results.

·         Performed extensive System and Integration tests on the latest releases.

·         Tested applications delivered via web browsers MSIE, Netscape on a variety of client platforms Windows 95/98/2000/NT, Macintosh, Safari and AOL.

·         Used SQL Server for backend testing and bugtracker tool to report bugs.

Nov. 2002 -               TODD Video Network Management, Inc. - Minneapolis, MN

Dec. 2003              Quality Assurance Analyst

·         Full-employee with the company from Nov. 2002 through Dec. 2003.

Nov. 1999 -               Benchmark

 

Nov. 2002              Quality Assurance Tester

                            TODD Video Network Management - Minneapolis, MN

·         Contract employee with Benchmark assigned to TODD until hired full-time by TODD.             

                            Quality Assurance Tester (continued)

·         Reviewed software requirements and specification documents for multiple products.

·         Designed, planned and developed testing methodology for functional, integration and performance testing using both manual and automation processes.

·         Performed unit, system and regression tests of all software releases.

·         Tested applications delivered via web browsers (IE, Netscape) on a variety of client platforms (Windows 95/98/2000/NT.

·         Tracked bugs found during testing using Rational Clear Quest, interacted with the software developers in resolving operational issues.

·         Participated in status meetings to discuss and resolve technical issues. 

·         Wrote SQL statements to query and examine the database contents

 

July 1999 -               Ameritech - Chicago, IL

Nov. 1999              Quality Assurance Tester

                            Chicago Hoffman Estates

·                                                          Assisted in the conversion of systems from Netcom to PeopleSoft Financial.

 

Nov. 1998 -               Crescent Nursing Home – Detroit MI

July 1999              Quality Assurance Tester

·                                              Responsible for system to manage patients, doctors and medicines.

Education: BS - Mechanical Engineering