Betzaida C. Arguello
Principal Engineer, Software Design Quality @Olympus Corporation
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WORK HISTORY
Principal Engineer, Software Design Quality @Olympus Corporation
EDUCATION
Villanova University
Certificate, Lean Innovation Management
Boston University
B.S. in Systems Engineering, Control Systems
BSI Training Academy
Internal Auditor Certification, Auditing per ISO 13495:2016 and ISO 19011:2018
Institute for Personal Leadership (IPL)
Strategic Influencing
Villanova University
Lean Six Sigma Black Belt, LSSBB
Universidad de Puerto Rico
M.S., Electrical Engineering
Caltech
Postgraduate Program, DevOps
Georgia Institute of Technology
Master of Science in Analytics
SKILLS
ABOUT BETZAIDA C. ARGUELLO
Fine Print: the opinions that I may express in this site are my own, and they do not reflect the opinion, view or position of my current employer, any other person or entity.Quality Leader with 23 years of work experience in the process development and manufacturing of electro-mechanical medical devices in FDA regulated environments, with practical knowledge of global Regulatory standards/regulations applicable to electrical medical equipment, SiMD, SaMD, and MDDS.Work experience includes- Managing engineering projects to bring customer satisfaction and manufacturing fulfillment through the leadership of cross-functional teams- Ensuring conformance to current regulations/standards, monitoring regulations/standards for revisions, leading engineering changes necessary to comply with new revised regulations/standards and reduce the cost of quality-Experience integrating Risk Management per ISO 14971:2019 as part of design controls and practical experience implementing IEC 62304 as part of Quality Management Systems for SaMD and medical devices with embedded software-BSI Certified Internal Auditor (Certificate Number 30••••••••12)
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