Yashwanth Reddy Mallapalli

[email protected]
480 273 8948
Individual with thorough experience about validation protocols, risk assessment and product
development cycles of medical devices, intends to work as a medical device quality engineer for a
leading organization.

 A Verification & Validation Engineer with Five years of experience in Quality Management
Systems, Change Controls, Equipment and Process Validation for Medical Device Industries. 
 Quality Engineering professional with experience in CAPA, lean manufacturing, six sigma,
qualification, validation and process design. 
 Strong experience in quality engineering statistical analysis, quality improvements, strategic
planning and compliance (21 CFR Part 11, 210, 211,820 and ISO 13485). 
 In-depth understanding of quality engineering disciplines, e.g. Design of Experiments (DOE), Six
Sigma (DMAIC), Control Charts, Statistical Process Capability (SPC), Measurement System
Analysis (MSA), Gage Capability Studies and Gage R&R Studies and Process Failure Mode
Effect Analysis (pFMEA). 
 Good Knowledge on Root Cause Analysis, Corrective and Preventive action(CAPA) and Failure
Mode Effect Analysis(FMEA).
 Validation protocols/reports (IQ, OQ, & PQ), Validation Master Plan (VMP), Configuration Master
Plan, Test plans / scripts, requirements matrix and Validation summary reports.
 Proficient in validation of Smart Workbenches, Barcode Scanners, Label Printers, Bit Trays, Pick-
to-Lights, Tool Plate Mounting Station Readers, Torque Drivers, EFD Valvemate 8000 Dispensing
System, G.P. Reeves Lubrication System, HVAC, Silastic Coating Machine and Clean Room. 
 Determined Process Inputs and Process Outputs, Process Parameters, Process Dominance
Factors, Critical Quality Attributes (CQAs), developed Sampling Plans and determined Sample
Size for Performance Qualification (PQ). 
 Highly skilled in planning, implementation, software development, testing, validation and System
Development Life Cycle of a project with major emphasis on quality regulations as governed by
the FDA, DEA and EMA.
 Good Experience with reviews, statistically analyzes, and documents pass/fail conclusions on
gathered data.
 Used Kaye Validator for temperature mapping of Controlled Temperature Units. 
 High degree of proficiency in developing and reviewing Validation Protocols, Validation Plans,
Test Method Validation Protocols and Validation Summary Reports. 
 Involved in gathering documents and interviewing people for 510K submissions. 
 Proven skills of implementing internal quality audit program and hosting external audits. 
 Good proficiency in electronic systems (SharePoint, TrackWise) and MS Office. 
 Experience of developing Standard Operating Procedures (SOPs), test plans, test cases
andvalidation deliverables including VMP, IQs, OQs, PQs, VSR, Requirement Traceability Matrix. 
 Experience working with Document Management System (DMS) like SharePoint to store and
retrieve documents. 
 Performed Risk Assessment using Process Failure Mode effect Analysis (pFMEA) and Risk
Management File (RMF). 
 Experience in performing GAP analysis and preparing Remediation Plans. 
 Ability to work efficiently in both individual and team based environments. 
 Strong time management, problem-solving, decision-making, judgment and team-oriented skills
for participating in multiple projects of varying complexity.

Work Experience:

Terumo Cardiovascular Group, Ann Arbor, MI (Nov’17 to Present)

Validation & Verification Engineer

 Medical Device Verification and Validation Engineer for all FDA, Computer Systems,
Manufacturing and Equipment validations.
 Software QA experience in Medical Devices with knowledge or experience in FDA Quality System
regulation, including FDA guidance on the General Principles of Software Validation.
 Generating techniques of quality-engineering to test medical devices 
 Providing expertise, training, and support to business clients and developers, to assist them
bringing regulated and non-regulated systems in compliance with existing industry’s regulations.
 Validating system that provide functionality within the Quality Assurance (QA), Call Center (CC),
Pharmacovigilance (PV), Regulatory (RA) and Medical Information (MI) departments, to capture
and respond to Product Information Requests (PIR) and Product Complaints (PC).
 Validating, evaluating and qualifying process management tools, GxP computer system as LIMS,
Argus, CTMS, PharmaReady and document management systems as TrackWise, EDMS,
Documentum.
 Designed the test fixture to detect intermittent connection in Percutaneous Lead and performed
test method validation (TMV).
 Review tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements,
troubleshooting issues, second tier application support and routine master data configuration as
required within the LabWare LIMS application.
 Created and implemented ISO and FDA compliant templates to be used
in verification and validation processes  
 Providing support to the senior medical device engineers in manufacturing and installing
medicaldevices.
 Involved in development and execute Test Method Validations (TMVs), develop, execute, review
and approve Validation protocols (IQ, OQ, and PQ) and reports.
 As a member of decision making group, involved in assessing computerized systems for
regulatory applicability and regulatory compliance.
 Responsible for maintaining Quality System Regulations (Part 820) and Regulatory Standards
(ISO 13485/14971). 
 Developing and executing project validation deliverables, such as; Validation Plans, Migrations
Plans, IQ/OQ/CQ, System, Integration and UAT test scripts. Designing Development Summary
reports, Trace matrices, System Maintenance Manuals, Disaster and Back-up and Recovery
plans, Validation Reports and other documentation deliverables required by the internal SDLC
and Change Control polices.
 Reviewing, recommending, and implementing process improvement techniques to increase test
quality and improve test productivity.

Baxter Healthcare, Round Lake, IL (Aug’16 to Oct’17)

Verification/Validation Tester
 Using a risk-based approach, provided guidance on System Development Life Cycle (SDLC) and
Computer System Validation (CSV) requirements for the implementation of all computer systems
in compliance with Ricon Pharma's Quality Management System and GxP regulations.
 Supported quality design assurance activities for Class III medical devices by remediating the
Design History File (DHF) that includes Customer Requirements, Product Requirements, System
Level Requirements, Hazard Analysis, Design FMEA and Process FMEA.
 Conducting medical device verification and validation by performing test procedures according to
written instructions.
 Supported training of personnel in requirements of quality tools and techniques, QMS based on
ISO 13485 and FDA 21 CFR 820 regulations.   
 Provided quality-engineering support on the various phases of product development life cycle
such as design verification, design transfer, process validation, design validation, product
performance qualification (PPQ) and post-market review to mitigate the outstanding concerns. 
 Developed and executed protocols for Test Method Validation (Gage R&R) and developed
Process FMECAs.
 Act as subject matter expert in root cause analysis and failure mode effect analysis (FMEA).
 Mentor investigators during root cause analysis and remediation efforts.
 Testing in a Medical Device Verification and Validation Environment   
 Applied quality engineering practices and guidance to support project teams and manufacturing
operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans. 
 Utilized statistical methods, such as, process capability data analysis, statistical process control
(SPC), sample size and frequency selection to ensure processes capability and repeatability. 
 Developed and updated assembly procedures to be more efficient and ergonomic. 
 Designed the test fixture to detect intermittent connection in Percutaneous Lead and performed
test method validation (TMV).
Terumo Cardiovascular Group, Ann Arbor, MI (Sep’15 to Jul’16)
Validation Engineer
 Worked with cross-functional team on a project to implement a quality control dashboard system
to identify and contain at-risk-ware. 
 Processed SOP Auditor to ensure manufacturing processes were up to date with current SOP
changes and ensured global manufacturing plants were current with document updates. 
 Developed and reviewed documents for Process Validation (IQ, OQ, PQ), Master Validation
Plans, Test Method Validation (Gage R&R), Process FMECAs.
 Worked within cross-functional group to identify Design/Process deficiencies as found by FDA. 
 Coordinated with Quality and Regulatory supervisors to ensure products and processes met
cGMP and FDA standards. 
 Performed Risk assessments including design and process FMEA. 
 Performed medical device product verification/validation (V&V). 
 Wrote, reviewed, and approved Change Orders to improve manufacturing processes and quality
procedures. 
 Performed design analyses and manufacturing process characterizations and developed
functional tests to understand device performance. 
 Created, reviewed, edited, and approved Change Orders to support R&D, Manufacturing,
Regulatory Affairs, and Quality improvements. 
 Worked on project CAPA investigation and resolution teams, overall risk analysis and in process
PFMEA (Process Failure Mode and Effects Analysis).
 Responsibilities included design for manufacture-ability (DFM) of diagnostic and therapeutic
catheters, insulin infusion kits, pain management kits, gastric bands; developed delivery
schedules/cost and process capability. 
 Performed risk assessments including design and process FMEA on a regular basis.

Biomet 3i, Palm Beach Gardens, FL (Mar’14 to Aug’15)

Validation Analyst
 Close interaction with designers and software developers to understand application functionality
and navigational flow. 
 Prepared test data for Positive and Negative testing. 
 Implemented cGxP (GMP, GLP, GCP) and GAMP4 guidelines in the systems. 
 Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11
regulations. 
 Involved in executing the test scripts to test the interface between LIMS system. 
 Developed the Test Scripts to generate the Audit Trail reports to verify the creation, modifications
to the records are captured in audit trail table logs. 
 Review and approve change control documentation. 
 Use HPQC to review and approve test cases, results, and defects. 
 Monitor and Advise on quality of all deliverables and report to management. 
 Review and approve Post execution of OQ test cases and defects.