Guillermo Diaz
Quality Compliance Engineer
MANSFIELD,MA
Summary
Quality Compliance Engineer adept at investigating and driving to resolution quality incidents. Detail-oriented team player with strong organizational skills. Passionate about team building and implementing quality with participating members of quality events and incidents. Strong attention to accuracy with the ability to work in fast-paced team environments. Looking forward to grow professionally while tackling and learning the quality needs of biomedical and pharmaceutical industries.
Overview
7
7
years of professional experience
5
5
years of post-secondary education
1
1
Certification
2
2
Languages
Work History
Compliance Engineer
4G Clinical
02.2021 - Current
- Investigated production issues and core product issue with resolution as needed
- Conducted root cause investigations of production issues and facilitate root cause analysis sessions for business teams as needed
- Acted as the liaison between groups for production issues that warrant incident or CAPA reporting or escalated issues that require cross-functional facilitation
- Created deviations, CAPA and incident reports
- Conducted research to test and analyze feasibility, design, operation and performance of equipment, components, and systems.
- Participated in regular meetings with stakeholders to review progress on quality improvement projects, fostering transparency and collaboration across departments.
Software Test Analyst
4G Clinical
09.2018 - 02.2021
- Tested client RTSM applications to ensure study level applications are tested appropriately to deliver a high quality, validated system to clients
- Provided support to Managers on day operations in support of RTSM applications
- Responsible for operational testing required for study applications
- Developed training materials and train Customer Support staff on study application support procedures and client standards
- Identified operational business needs and collaborate with product development to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness
Customer Support Associate
4G Clinical
01.2018 - 09.2018
- Responsible for handling calls from new and existing customers regarding a variety of IRT Support requests
- Troubleshoot issues by clarifying, researching, implementing solutions and escalating unresolved problems
- Ensure communication is properly documented in the Event Tracking tool
Education
B.S. - Bioengineering
Syracuse University
Syracuse, NY 06.2012 - 05.2017
Skills
Quality management systems
Documentation control
Quality control tools
Internal auditing
Quality metrics monitoring
CAPA management
Corrective action planning
Validation techniques
Problem-solving
Quality processes
Statistical analysis skills
Compliance monitoring
Accomplishments
QA Masters Training by Lincoln Health Network QA
Certification
ISTQB CTFL- Certified Tester, Foundation Level
Timeline
Compliance Engineer
4G Clinical
02.2021 - Current
Software Test Analyst
4G Clinical
09.2018 - 02.2021
ISTQB CTFL- Certified Tester, Foundation Level
08-2018
Customer Support Associate
4G Clinical
01.2018 - 09.2018
B.S. - Bioengineering
Syracuse University
06.2012 - 05.2017
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