Francielli Guaba
@francielliguaba
I build audit-ready medical device quality systems, CAPA workflows, and risk-based quality improvements.
Dominican RepublicWhat I'm looking for
At Jabil Healthcare, I maintain and improve medical device QMS processes across CAPA, investigations, change control, document control, complaints, metrics, and audit readiness.
I lead root-cause investigations, support roughly five medium/high-risk complaints weekly, develop Power BI Management Review dashboards, and coordinate responses to audit findings and quality-system gaps.
Previously, I owned quality deliverables for three new product introductions at Jabil, applying ISO 13485, FDA 21 CFR Part 820, FMEA, validation, and quality documentation from concept through production kickoff.
At Hayco, I built the company’s first medical-device QMS and QC processes from the ground up, preparing the organization for an ISO 13485 audit with zero findings.
Experience
Work history, roles, and key accomplishments
Global Sustaining / Quality Systems Sr. Engineer
Jan 2022 - Present (4 years 8 months)
Maintain and improve QMS processes for regulated medical device operations, leading CAPA investigations, change control, and audit readiness. Develop quality metrics and dashboards, support risk management and NPI activities, and supervise quality staff.
Served as primary Quality owner for 3 new product introductions, coordinating quality deliverables across cross-functional teams. Applied ISO 13485, FDA 21 CFR Part 820, risk management, and validation to support product and process readiness.
Quality Assurance Engineer
Hayco
Jan 2013 - Dec 2019 (6 years 11 months)
Implemented the company's first medical device and built the foundational Quality System and QC processes from the ground up. Created FMEA and Control Plan, developed quality procedures, and prepared the organization for an ISO 13485 audit that concluded with 0 findings.
Education
Degrees, certifications, and relevant coursework
Universidad Internacional Iberoamericana
Master's Degree, Project Management
Master's degree in Project Management from UNINI / UNEATLANTICO.
Universidad Autónoma de Santo Domingo
Bachelor's Degree, Industrial Engineering
Degree in Industrial Engineering from Universidad Autónoma de Santo Domingo (UASD).
EF SET
EF SET English Certificate, English
Grade: C2
EF SET English Certificate with C2 proficiency.
Availability
Location
Dominican RepublicAuthorized to work in
Salary expectations
Job categories
Skills
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