Francisco Ramos
Acton,MA
Summary
I've had the opportunity to hold Quality Engineering and Quality Assurance roles in the Medical Device industries for my entire career. Throughout this journey I have demonstrated the ability to deliver results by developing and executing innovative solutions to address key business challenges. I specialize in developing and implementing solutions that reduce business risk while positively impacting quality. Wide-ranging knowledge of Quality Systems and Quality Systems Management as well as Operations and Engineering.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Solution Test Lead
W.L. Gore and Associates
Flagstaff, AZ
01.2023 - Current
- Provided leadership, guidance, and training in test case development to multi-functional internal teams and System Integrators
- Collaborated with business units to align teams in identifying, designing, and developing test plans and test cases that meet end-user needs
- Tracked and managed defects, ensuring quick resolution by actively engaging with developers and Business Process Experts
- Developed a detailed test strategy for SAP S/4HANA Solution, serving as a blueprint for testing activities and ensuring a structured approach
- Provided leadership and guidance on requirements and test cases using risk-based approach
- Led Functional and User Acceptance Testing (UAT) events, consolidating and analyzing findings, and preparing daily comprehensive reports for middle and upper management
MES Quality Assurance Lead
W.L. Gore and Associates
Flagstaff, AZ
01.2018 - 01.2023
- Lead the coordination of build component such as reports, labels, and functional solution validation
- Collaborated with solution implementation teams on defining and designing new labels in support of system implantations
- Authored functional design components for new build items
- Collaborated with IT Technical resources on the build of new functionality
- Lead MES Solution Functional testing activities including coordination with MES QA and IT SQA to ensure alignment to procedures and processes to validated solution state
- Established and maintained strong relationships with key stakeholders, including Manufacturing leadership, Quality, and IT, to ensure effective communication and collaboration throughout the design and implementation process
- Responsible for leading and developing a division wide Camstar MES Solution Validation Strategy
- Strategy established functional components reusability which decreased build time, component development capital investment, and component validation time
- Developed change control process to assess and evaluate impact to MES
- Reduced time to train end users by developing and implementing interactive MES NCR training module
- Interacted and communicated with Quality Leadership and management organization, working through governance issues
- Organized, validated, and implemented standard eDHR reporting in compliance to global DHR requirements
- Developed and implemented paper to system Master Data loading process
- Defined User Acceptance Testing (UAT) process model and authored protocols and reports
- Provide functional leadership and direction to MES QAs
Senior Quality Engineer
Med-Chem Products
Woburn, MA
01.2017 - 01.2018
- Lead CAPA from initiation to effectiveness and closure
- Used statistical tools and methodical approach (DMAIC) for defect trending, root cause analysis and test method validation
- Owned and implemented nonconformance reports for raw materials, components, and final assembly
- Lead JD Edwards E1 ERP plant wide cutover/ implementation tasks
- Conducted root cause analysis integrated with corrective actions on over 60 nonconformances
- Mentored junior engineer on IQ/OQ/ PQ Validation Process, Material Review Board and Nonconformance reports
- Developed and implemented process changes for production compliance using Failure Modes and Effects Analysis (FMEA)
Quality Assurance Professional
W.L. Gore and Associates
Flagstaff, AZ
01.2013 - 01.2017
- Developed effective partnerships with internal staff to facilitate the timely identification and resolution of deviations
- Provided direct support to Quality rep in preparation for, conduct of, and follow-up activities associated with site visits from regulatory/accrediting agencies
- Review and approval of equipment validations, test method validations, and software protocol and reports
- Managed, coordinated, and approved all final QC and destructive test nonconformance investigation and corrective actions
- Lead corrective and preventive actions to eliminate the source of error from a staging area susceptible to product mix-up
- Supported design control projects from Design Inputs through design transfer and supported manufacturing process validation
- Functional direction of Document Control personnel and systems
Education
Bachelor of Science - Industrial Engineering
Polytechnic University of Puerto Rico
Hato Rey, PR06.2012
Skills
- Leadership
- Project Strategy
- Lead Auditor
- Teamwork
- Strategic Issue Resolution
- Analytical Thinking
- Collaborative Team Engagement
- Six sigma methodologies
- Quality assurance management
- Practical engineering skills
Certification
- Lead Auditor
- CSSGB
- CQE
- CSQE
Timeline
Solution Test Lead
W.L. Gore and Associates
01.2023 - Current
MES Quality Assurance Lead
W.L. Gore and Associates
01.2018 - 01.2023
Senior Quality Engineer
Med-Chem Products
01.2017 - 01.2018
Quality Assurance Professional
W.L. Gore and Associates
01.2013 - 01.2017
- Lead Auditor
- CSSGB
- CQE
- CSQE
Bachelor of Science - Industrial Engineering
Polytechnic University of Puerto Rico
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