Summary
Overview
Work History
Education
Skills
Websites
Certification
Languages
Accomplishments
Timeline
Generic

Cesar Vargas Rondon

Santo Domingo

Summary

As a CAPA Engineer, I have extensive experience in managing complaints, corrective and preventive actions, root-cause analysis to ensuring top-notch product standards and customer satisfaction. My career has allowed me to develop strong problem-solving abilities, expertise in process improvement, and effective collaboration across different teams. I excel in dynamic environments and enjoy leveraging my skills to implement meaningful solutions. I am dedicated to staying up to date with industry advancements and maintaining a high level of professional excellence. I look forward to connecting with you to discuss how my skills and experience can contribute to the success of your team.

Overview

3
3
years of professional experience
1
1
Certification

Work History

CAPA Engineer

ConvaTec
Haina , Dominican Republic
01.2024 - Current
  • Facilitate the tracking and closure of Corporate CAPAs addressing company-wide Corrective and Preventive actions.
  • Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness
  • Facilitate the tracking and closure of corporate Nonconformances (NCs) to ensure consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality and thoroughness of content.
  • Coordinates across cross-functional CAPA / NC teams and ensures compliant and appropriate documentation of CAPA and NC activities from owners
  • Support Sr. Manager CAPA and Metrics by contributing to process improvements, innovative solutions, and training to standardize processes globally and to meet the changing regulatory compliance environment and compliance goals while minimizing complexity of implementation for Integra organizations
  • Facilitate quality metrics gathering, analyzing and reporting on a regular and ad hoc basis. Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization (site, division and corporate) for input into NC / CAPA or for assessment of key quality system processes
  • Maintain current knowledge of FDA and any other applicable international Quality System regulations for medical devices and human tissue products.

Quality Engineer I, Investigation

Fresenius Kabi
01.2022 - 01.2024
  • Leading and collaborating objectively with local team members to achieve consistent process while identifying process improvements to drive efficiency and compliance
  • Assist in the process of complaints and investigations related to suppliers
  • Coordinates additional investigations related to escalated complaints on time reporting to the FDA and other Regulatory Agencies
  • Escalate customer feedback regarding quality-related processes
  • Collaborate with PMQ Quality Engineers on trends, complaint investigation activities, and process improvements, as needed
  • Receives investigation results for possible communication of complaint investigation results to customers
  • Process results of samples returned by the client to translate them into needs for improvement in the manufacturing process
  • Participate as a leader in the maintenance of the Corrective and Preventive Action System (CAPA) related to customer complaints
  • Perform the compliant closure using the applicable system (SAP)
  • Supporting reviews and audits as required.

Quality Eng. Jr, Complaints

Fresenius Kabi
01.2021 - 01.2022
  • Receive, evaluate, and investigate customer complaints
  • Ensures timely and accurate evaluation and processing of customer complaints to help ensure the accomplishment of all its regulatory obligations
  • Collaborating investigations related to external customer complaints to determine the root cause of the reported defect and measure the effectiveness of actions through trend analysis.

Education

Bachelor's Degree in Industrial Engineering -

UNAPEC

Skills

  • Problem-solving
  • Quality Management
  • Team Player
  • Statistical Analysis
  • Team Collaboration
  • Critical Thinking
  • Attention to Detail
  • Root Cause Analysis
  • Project Scheduling
  • Documentation And Reporting
  • Failure Investigation and Analysis
  • Process Mapping
  • SOP Development

Certification

  • Scrum Fundamentals, 2022, Scrum Study
  • Microsoft Exel -Beginner to advanced, 2020, Scrum Study
  • Management of Corrective Actions and Continuous Improvement, 2022, INFOTEP

Languages

  • Spanish, Mother language
  • English, Intensive CAE-C1, 2015

Accomplishments

  • Backlog reduction (60%) in the number of complaints for a family of products ensuring product reliability in the U.S. market through a Corrective and Preventive Investigation (CAPA) to mitigate solvent migration and prevent proper functionality.

Timeline

CAPA Engineer

ConvaTec
01.2024 - Current

Quality Engineer I, Investigation

Fresenius Kabi
01.2022 - 01.2024

Quality Eng. Jr, Complaints

Fresenius Kabi
01.2021 - 01.2022

Bachelor's Degree in Industrial Engineering -

UNAPEC

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Cesar Vargas Rondon