Upender Reddy Vellinki

FAQ About Upender Reddy Vellinki

• What is Upender Reddy Vellinki's address?

  Upender Reddy Vellinki is located at
  United States

• What is Upender Reddy Vellinki's job title?

  Upender Reddy Vellinki is a
  • 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 Amgen

• What industry does Upender Reddy Vellinki currently work in?

  Upender Reddy Vellinki currently works in the
  Amgen

• What is Upender Reddy Vellinki's area of expertise?

  Upender Reddy Vellinki specializes in
  • 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

• Which languages does Upender Reddy Vellinki speak? 

  Upender Reddy Vellinki speaks the following languages:
  No languages available.

• Which industries has Upender Reddy Vellinki previously worked in?   

  Upender Reddy Vellinki has prior experience in the following industries:
  Amgen , Baxter International , Medtronic , Zimmer Biomet

• What is Upender Reddy Vellinki’s work experience?  

  Upender Reddy Vellinki has the following professional experience:
  Amgen , Amgen , Baxter International , Medtronic , Zimmer Biomet .

• How can I find Upender Reddy Vellinki on LinkedIn?  

  You can view Upender Reddy Vellinki’s
  LinkedIn profile at LinkedIn URL.

• What are Upender Reddy Vellinki’s work email addresses?  

  Upender Reddy Vellinki’s work email addresses are
  [email protected] .

• What company does Upender Reddy Vellinki work for?  

  Upender Reddy Vellinki works at
  Amgen