Marie Benedicto-Reglin

• Plan and schedule EN/ISO 13485, MDSAP, EU MDR, EC MDD Quality Management System (QMS) Audits for medical device clients o Form a team of knowledgeable experts with matching skills and experience o Coordinate audit schedules with client and audit team o Perform administration functions of project financials o Maintain project information quality and integrity • Oversee audit quotation, subcontracting, registration and submission for pre- and post- audit Certification Body approval

• Prepare audit quotes, draft subcontracts, and support order fulfillment • Review and submit audit registration/submission files for EN/ISO 13485, MDSAP, EU MDR, and EC MDD medical device certification • Provide ad hoc reporting of quote, registration, submission statuses • Familiarize self with proprietary databases (PSE, CBW, Medicen, Medici, etc.)

• Assisted patients in scheduling of appointments • Responded to patient queries regarding COVID-19 testing, tests offered and costs, and issues with patient portal

• Improved customer service through standard response creation • Conducted outbound product and inbound QA/QC logistics

• Provided administration and management support of design and construction contracts for Wastewater and Park facilities o Reviewed pre-design reports to create consultant scope of services, project cost estimates and refine project schedules o Provided QA/QC review and coordinated city wide plan check and internal/external agency permitting of design plans o Supported the preparation of specifications and contract documents in the solicitation of bids o Monitored project budgeting and accounting

• Designed and revised in-house PCBs for cable and software testing • Supported QA/QC by improving test procedure documentation

Relevant Courses: Circuit Analysis, Electric and Magnetic Fields, Electromagnetic Waves, Electrical Energy Conversion, Fundamentals of Engineering Electronics, Analysis and Design of Electronic Circuits, Electronic Materials and Devices, Computational and Statistical Methods for Electrical Engineers, Feedback Control Systems, Introduction to Computer Programming, Digital Systems, Computer and Data Networks