AKSHIT REDDY LUCKY REDDY
Warsaw,IN
Summary
Dynamic Project Manager and Certified Quality Engineer with a proven track record leading high-impact projects. Expert in Quality Assurance, Project Management, and Lean Six Sigma Methodologies, demonstrating exceptional leadership and problem-solving skills to drive continuous improvement and innovation.
Overview
9
9
years of professional experience
Work History
Engineering Project Manager
ZIMMER BIOMET
05.2022 - Current
- Directed the global development of packaging designs for over30,000+ SKUs, implementing optimized packaging systems across7+ manufacturing sites and5+ vendors
- Achieved full integration of packaging designs and clinical process efficiencies, resulting in $7M+ in annual savings across all locations
- Managed25+ contractors for the EU MDR project, leading large-scale transitions to comply with new EU MDR guidelines, including packaging, labeling, biocompatibility, and technical files
- Led end-to-end packaging supply chain projects, ensuring adherence to performance standards, budget, schedules, and quality metrics, leveraging advanced project management tools
- Delivered a high-profile mixed-reality platform project by enhancing the implant models into Microsoft Holo Lens to the Chief Technology Officer
- Develop design prototypes, software, and process project plans needed to create a manufacturable product, meeting the performance requirements of the medical device packaging groups
- Managed all phases of Global NPI Biocomp projects including planning, requirements definition, design, verification, validation, design transfer, and risk management
- Oversight of required changes and implementation processes, coordinating cross-functional interactions and driving timelines to meet business needs with stakeholders from Planning, Procurement, Manufacturing, Regulatory, Quality, Compliance, and Marketing
- Collaborated with Development and Production Engineering, Customer Support, Logistics, and Procurement to meet performance and quality expectations for end users
- Conducted data analysis to identify trends in key processes, collaborated on root cause analysis, and implemented solutions
- Software: Microsoft Project, Planview, Smartsheets, Microsoft Visio, MS Excel, JD Edwards, Tableau, Vault, MS Office
Senior Quality Engineer
ZIMMER BIOMET
05.2016 - 05.2022
- Conducted technical investigations, root cause analysis, and risk assessments for Class I, II, and III medical device failures
- Developed and maintained the CAPA (Corrective and Preventive Action) quality system, providing comprehensive support to the business unit
- Collaborated in cross-functional teams to escalate and resolve quality issues, coordinating with domestic and international manufacturing sites, suppliers, and distribution partners
- Responded to inquiries from regulatory bodies, including the US FDA, EU Vigilance, and other notified agencies
- Led bi-weekly CAPA and complaint board reviews, preparing presentations for monthly quality management reviews
- Supported audits by addressing CAPAs, conducting root cause analyses, managing manufacturing investigations, and preparing detailed investigation reports
- Authored concise and accurate failure analysis reports for healthcare professionals and regulatory bodies
- Conducted risk assessment activities using Failure Mode and Effects Analysis (FMEA) to identify failure modes and determine corrective/preventive actions
- Proficient in blueprint reading, including advanced Geometric Dimensioning and Tolerancing (GD&T)
- Ensured quality issues were managed according to procedures and that effective preventive actions were implemented
- Created and updated Design History Files (DHF) to reflect changes in product design, ensuring compliance with regulatory standards
- Worked with interdepartmental teams to drive continuous product improvements and address cross-departmental projects
- Utilized continuous improvement tools such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP, and process mapping to enhance product quality and processes
- Software: EtQ Reliance, ENOVIA, Infor XA, Doc Viewer, Plot Viewer, Tableau, MS Office Suite, Visio, Query tool, JD Edwards, Aspen plus, AS400, Oracle WebCenter, VAULT
Quality Engineer
U.S. Department of Veteran Affairs
10.2015 - 05.2016
- Assisted on inventory mapping, cost reduction, and procurement strategies with Veteran Affairs health care center at multiple sites and managed the Customer Request for Information system
- Led a cross-functional CAPA team and performed quality assurance tasks such as using the Fishbone diagram and the Five Whys technique in order to consistently produce effective solutions to analyze consumer complaint data and develop projects to reduce consumer complaints
- Collected and analyzed data for Gage failures and Product Evaluation for Patient Safety and Risk analysis
- Conducted Cycle Time Analysis and Line Balancing of high-volume production line
Education
Master of Science (M.S) - Industrial Engineering (Major in Quality)
University of Houston
Houston, TX05.2015
Bachelor of Technology (B.S) - Mechanical Engineering
SRM University
05.2013
Skills
- Certified QE
- Quality Assurance
- Project Management
- Productivity Improvement
- Certified Lead Auditor
- Computer Languages: C, My SQL
- MS Suite: Excel, Access, Word, PowerPoint
- Quality Tools: Root Cause Analysis, FMEA, SolidWorks, AutoCad Lean Tools, Value Stream Mapping, Dynamic,8D,5S, MSA, CAPA/FA
- Courses: Lean Six Sigma Methodologies, Statistical Process Control, Process Planning, Regression Analysis, Quality Control
Timeline
Engineering Project Manager
ZIMMER BIOMET
05.2022 - Current
Senior Quality Engineer
ZIMMER BIOMET
05.2016 - 05.2022
Quality Engineer
U.S. Department of Veteran Affairs
10.2015 - 05.2016
Bachelor of Technology (B.S) - Mechanical Engineering
SRM University
Master of Science (M.S) - Industrial Engineering (Major in Quality)
University of Houston
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