Libi Suresh
Edmonton,AB
Summary
Dynamic Project Management Professional , adept at project monitoring and quality control. Successfully executed product changes and implemented UDI, enhancing operational efficiency. Proven ability in schedule management and cross-functional collaboration, driving stability studies for Class 1 and 2 medical devices while ensuring regulatory compliance. Over the course of 10 years, I have held various positions, progressing from Specification Associate to Product Development Specialist and ultimately to Change Control Specialist.
Overview
14
14
years of professional experience
Work History
Change Control Specialist
PRIMED Medical Products
08.2015 - Current
- Supported project management by providing technical expertise in integration, design and commissioning of new product lines.
- Responsible for performing technical reviews of projects/products and preparing technical documentation as per procedures.
- Supporting quality assurance and regulatory activities as required.
- Responsible for executing changes to existing products and bring on products for new customers.
- Supported UDI(Unique Device Identifier ) implementation for different projects.
- Responsible for developing,implementing and continually improving product lines.
- Ensures the programs under its purview are functioning effectively.
- Tested products for functionality or quality and troubleshot problems with equipment, devices, or products.
- Supported Stability Project for Class 1 and 2 medical devices by managing and executing stability studies, ensuring timely testing, cost management,schedule management, data management, and regulatory compliance, while also collaborating with cross-functional teams to meet stability needs for clinical programs
Programmer Analyst
Cognizant Technologies Solutions
06.2011 - 09.2012
- Provided ongoing support for users experiencing issues or requiring assistance with application functionality.
- Contributed to successful project completion with effective time management and prioritization skills, meeting tight deadlines consistently.
- Collaborated with cross-functional teams to ensure seamless integration of new features into existing applications.
- Provided technical support using knowledge of complex technology to solve problems and support new projects.
- Optimized code quality through regular peer reviews, resulting in fewer defects and easier maintenance.
Education
Project Management Professional (PMP) Certification - Project Management
Project Management Institute
Pennsylvania01-2025
Certificate - Microsoft Excel
University of Alberta
Edmonton, AB06-2022
Certificate - Auditing Stability Programs
CfPA - The Center For Professional Advancement
Online08-2021
Certificate - AUTOCAD
AUTOCAD
Dubai, UAE05-2015
Bachelor of Technology - Engineering
Amrita School of Engineering
India07-2011
Skills
- Requirements gathering
- Project planning
- Development milestone planning
- Scope management
- Quality control
- Schedule management
- Project monitoring
Languages
English
Full Professional
Hindi
Limited Working
Malayalam
Native or Bilingual
Arabic
Limited Working
Timeline
Change Control Specialist
PRIMED Medical Products
08.2015 - Current
Programmer Analyst
Cognizant Technologies Solutions
06.2011 - 09.2012
Project Management Professional (PMP) Certification - Project Management
Project Management Institute
Certificate - Microsoft Excel
University of Alberta
Certificate - Auditing Stability Programs
CfPA - The Center For Professional Advancement
Certificate - AUTOCAD
AUTOCAD
Bachelor of Technology - Engineering
Amrita School of Engineering
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