Upender Reddy Vellinki

About Upender Reddy Vellinki

Seasoned medical device professional with specialized Design quality assurance expertise, Risk Management (ISO 14971), MDD/EU MDR, Product Development. Proven ability to lead large teams to drive strategic initiatives towards business solutions, improve systems and streamline processes. Possess an effective interpersonal savvy with an aptitude to interact diplomatically to navigate complex challenges and drive successful results. • Experience in Quality Management Systems, Change Control, Software Development, Computer System Validation, Risk Management and Auditing. Extensive knowledge of cGxP, QSR, Part 11, ICH, HIPAA, EU Standards, ISO. • Hands on working understanding in Implantable, Peripheral Vascular, Cardiovascular, Electromechanical, Surgical Devices • Overall experience in MDR/Post Market Vigilance/Surveillance, Complaint Monitoring/Trending, Product Analysis, Investigations, Corrective and Preventive Actions, Medical Device Reporting, Adverse Events, Root Cause Analysis, Non-Conformances, Deviations, Failure Mode and Statistical Process Control. Excellent organizational, analytical and problem-solving skills. Always striving for Continuous Process Improvement.• Key Expertise in Communication and presentation skills, Technical writing, Process and system improvement, Microsoft Office, Data analysis, Minitab, SAP, Trackwise, and Agile, Project management• Diversified Senior Engineer specializing in 13485, 60601, 62304, and 14971 medical device analyses. • Wide-ranging board level to system level skills. Solid project management capabilities and consistent track record of leading verification and validation projects for global organizations in decent decree, remediation, and 483 of Class 2 and class 3 medical devices R&D/manufacturing. • Design Controls - design input, design review, design output, Verification and validation, Device history file, Identification and Traceability, Hardware Design Specifications, Complaint files, isolate or segregate Nonconforming Product investigation, failure analysis, root cause, corrective and Preventive Action, Risk estimation, Risk Assessment, FMEA, Post-production information, CAPA, Validation TMV/IQ/OQ/PQ protocols and reports, DHF reviewing• Production and Process Controls - Inspection, measuring, and test equipment Process validation, Statistical Process Control (SPC), Acceptance Activities, Critical component, change control, Device master record Quality system record, DHF

Experience

1. Senior System Engineer

   Amgen

   Aug 2023 — Present · Thousand Oaks, CA, US

Education

• Jawaharlal Nehru Technological University

  Bachelor of Technology - BTech, Mechanical Engineering

  2011 — 2015

• University of the Cumberlands

  Master of Business Administration - MBA, Project Management

  2020 — 2021

• Texas A&M University-Kingsville

  Master's degree, Mechanical Engineering

  2015 — 2016

• Texas A&M University-Kingsville

  Master of Engineering - MEng, Mechanical Engineering