Gloria Calderón Email & Phone Number

United States

Houston, Texas, United States

- Create and maintain software product development life cycle documentation, including software product descriptions, product user manuals, product labeling/indications for use, bill of materials, software requirements specifications, and implementation documentation in partnership with Engineering & Tech software development engineers.- Track quality system documentation through the software product development life cycle.- Maintain responsibility for Device Master Records ("DMR") and Design History Files ("DHF") at the close of each product project.- Assist the Engineering & Tech Dept. to create and maintain internal standard operating procedures, work instructions, and corresponding quality system documentation.- Function as an information source to Engineering and Tech and Product departments when quality issues arise.- Assist in investigation and resolution of non-conformances and complaints.- Assist in product validation and verification testing for new version release sprint testing.- Assist in the management of corrective and preventive actions (CAPA), perform investigations, root cause investigations, corrective action plan and implementation, and effectiveness verification plan and implementation.- Assist in the execution of internal and external audits.

Miramar, Florida, United States

- Coordinate corrective action plans and verification activities. Work with process owners to perform root cause analysis, correction planning, and corrective and preventive action implementation.- Manage and document the medical device complaint process, delegates issues to the appropriate parties for investigation and resolution.- Plan, execute and maintain documentation of Supplier Qualification and Tool Validation for third-party software products supporting the Agile SDLC.- Perform quality control and quality assurance testing of applications using a set of testing tools, testing framework, processes, and methodologies within the Agile SDLC.- Review and approve test cases for all documented requirements.

Miramar, Florida, United States

- Perform quality control and quality assurance testing of applications using a set of testing tools, testing framework, processes, and methodologies.- Make recommendations based on assessed risks to quality by applying various verification and validation techniques in coordination with the Developers, QA, and Managers.- Provide feedback on the production readiness of the software being tested, allowing management to make a well-informed decision regarding the release of software into production.- Create and document test cases for all documented requirements.- Manage and execute testing for all test cases including integration, certification, user acceptance, system, regression, and load tests.- Monitor, measure, and report metrics based on the results of all tests.- Conduct tests on computer software programs to make sure the programs perform properly and are easy to use.- Complete tests to determine weaknesses in software code and recommends program improvements or corrections to programmers.

Miramar, Florida, United States

- Ensure and coordinate site activities associated with the medical device manufacturing and testing comply with the quality management systems and applicable regulatory requirements.- Coordinate the Quality Management Systems ensuring compliance to all relevant regulations and standards including FDA* CFR Title 21/Part 820- Administers the document control system including monitoring, cataloging and reporting on the status and stages of various documents- Manage the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution- Manage the medical device nonconformance and Corrective Action and Preventative Action (CAPA) documentation related to software and processes failures including documentation related to adverse events such as Medical Device Reporting (MDR)- Review the Software Development Life Cycle (SDLC) documentation ensuring compliance with all relevant regulations and standards- Create and monitor reports for departmental Key Performance Indicators (KPIs), tracks and trends- Assist in the necessary documentation for new product market clearance to the FDA such as 510(k) applicationOther responsibilities and tasks included the following:- Organize documents for management review, software releases and audits- Coordinate and initiate on boarding quality and regulatory compliance training programs- Manage the medical device supplier qualifications- Review Software Tool Validation documentation- Mentor cross functional teams in Quality Systems- Provide administrative support to all Information Technology departments

Fort Lauderdale, Florida, United States

- Ensure and coordinate site activities associated with the medical device manufacturing and testing comply with the quality management systems and applicable regulatory requirements.- Coordinate the Quality Management Systems ensuring compliance to all relevant regulations and standards including FDA* CFR Title 21/Part 820- Administer the document control system including monitoring, cataloging and reporting on the status and stages of various documents- Manage the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution- Manage the medical device nonconformance and Corrective Action and Preventative Action (CAPA) documentation related to software and processes failures including documentation related to adverse events such as Medical Device Reporting (MDR)- Review the Software Development Life Cycle (SDLC) documentation ensuring compliance with all relevant regulations and standards- Create and monitor reports for departmental Key Performance Indicators (KPIs), tracks and trends- Assist in the necessary documentation for new product market clearance to the FDA such as 510(k) applicationOther responsibilities and tasks included the following:- Organize documents for management review, software releases and audits- Coordinate and initiate on boarding quality and regulatory compliance training programs- Manage the medical device supplier qualifications- Review Software Tool Validation documentation- Mentor cross functional teams in Quality Systems- Provide administrative support to all Information Technology departments

Pembroke Pines, Florida, United States

Main tasks as a Dental Insurance Coordinator:- Accurately verify insurance information and benefits- Promptly handled all patients’ inquiries related to billing concerns.- Document insurance breakdown in patient accounts including detailed benefits upon patient registration- Responsible for pre-certifications and authorizations for major dental treatment prior to patient appointment- Research, follow up and resolve open a pending insurance authorizations in a timely manner- Calculate copayments for patients upcoming visits and contact patients regarding financial responsibilities while my main tasks as an Accounts Receivable Specialist are shown below:- Manage the Insurance Coordinators team who oversee patient’s insurance eligibility and benefits for dental services prior to appointments- Manage claim payments in compliance with financial policies and procedures- Effectively negotiated pending balances with patients and dental insurance representatives- Communicate with insurance claims department regarding any claim discrepancy- Prepare end of the day and end of the month outstanding claim balances reports- Maintain and negotiate insurance fee schedules as well as management of patients refunds - Ensure that all posted checks are remitted via remote deposit and/or sent to the bank for deposit in a timely manner

Boston, Massachusetts, United States

- Assisting chair-side during general dentistry examinations according to standard safety practices, clinician needs, and study protocol requirements- Ensuring proper operation of dental and medical equipment and emergency supplies by completing routine inspections and maintenance- Monitoring clinic supplies and coordinate placing orders to maintain adequate stock- Taking x-rays as required by study protocols- Interacting with research participants to collect study data and perform procedures as appropriateAs part of this position I became a Licensed Dental Assistant in the states of Massachusetts. Additionally, I successfully completed the Radiology Certification for Dental Auxiliaries (RCDA) at the Boston University, Henry M. Goldman School of Dental Medicine.

Bethesda, Maryland, United States

- Flow cytometry staining of re-suspended human and mice gingiva immune cells from the mucosal tissue surrounding dentition- Management of genetically modified mice colony genotyping- DNA Extraction and DNA Amplification (Polymerase Chain Reaction analysis)- Real Time Polymerase Chain Reaction- Mice alveolar bone loss experiments- Collection, documentation, and record of scientific data for publication- Scientific and statistical representation of data collectedProject: On-going mechanical damage from mastication which drives homeostatic Th17 cell responses at the oral barrier.- Funding: NIH Intramural program of NIDCR. - Coordinator: Dr. Niki Moutsopoulos (Principal Investigator)

New Orleans, Louisiana, United States

As an Undergraduate Research Mentoring (URM) Program Laboratory Research Fellow at the Biological Science Department, I was part of the framework of the following research project:- National Science Foundation Project Title: Collaborative Research: URM: UNO/SUNO Partnership in Mentoring Undergraduates in the Biological Sciences- Funding: National Science Foundation (NSF) Award Number 1040996- Coordinator: Wendy Schluchter (Principal Investigator) & Carla Penz (Co-Principal Investigator)- Project R&T Thematic: “Resolving Relationships within Valerianaceae (Dipsacales): New Insights and Hypotheses from Low-Copy Nuclear Regions”The aim of the project was to conduct independent research mentored by faculty member Dr. Charles D. Bell. I took excellent knowledge of how biological and physical processes interact to drive evolution. Our project aimed to understand the phylogenetic inference at the species level among the major clades of Valerianaceae using chloroplast genome sequences.In the framework of the above project, my primary responsibility was conducting DNA extraction, amplification, DNA sequence and alignment. I was also responsible to analyze genetical data using the software Packages PAUP and Sequencer.

East Lansing, Michigan, United States

As a Summer Research Opportunities Program (SROP) Research Intern within the Animal Science department, I was part of the laboratory of Dr. Chen Chen which focuses on the molecular mechanisms underlying mammalian spermatogenesis. I enriched my knowledge regarding different Laboratory techniques used in the molecular, cellular, biochemical, genetics and genomics approaches. More specifically, I worked on the following:- Project: Characterization of the Serine/Threonine Kinase Domain of the Tudor protein STK31-TDRD8- Funding: Michigan State University Summer Research Opportunities Program- Coordinator: Dr. Chen Chen (Principal Investigator)In the framework of the above project, I took great knowledge of the genes and pathways influencing germ/stem cell self-renewal, differentiation and fertility with a current focus on the function of Tudor domain proteins associated factors in gene silencing, genome stability, epigenetics, stem cell biology and cancer.The following were my tasks:- Management of genetically modified mice colony genotyping- Immunofluorescence Staining Analysis (Paraffin fixation of animal tissue)- Molecular Cloning/Recombinant Protein Purification- Western Blot Analysis- DNA Extraction, Polymerase Chain Reaction (PCR) analysis, Real Time PCR