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At Abbott Cardiovascular, my commitment to patient safety and product excellence is demonstrated through rigorous adherence to global regulatory standards. With over 8 years at Abbott, my expertise in Medical Device Regulation (MDR) and Manufacturing Process Improvement has been pivotal in enhancing our quality assurance protocols.Within the Product Performance Group, we've fostered a culture of continuous improvement, ensuring devices meet the highest standards of safety and efficacy. Leveraging a high degree of technical competence and strong communication skills, my role is instrumental in analyzing customer feedback and driving process improvements that contribute to the betterment of patient outcomes.
Abbott Cardiovascular
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Analyst Product Performance GroupAbbott CardiovascularDenver, Co, Us
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Post Market Surveillance Analyst - Product Performance GroupAbbott Cardiovascular Nov 2015 - May 2024Quality Assurance Department, Product Performance Group. Medical Device Reporting to the Food and Drug Administration and other worldwide regulatory agencies of device malfunctions or adverse patient events.Analyze customer complaints to determine which are regulatory reportable. Serve as a contact for activities with internal, field, and end use customers. Responsible for adherence to, and interpretation and implementation of, Good Manufacturing Practices (GMPs) and proper complaint handling per the Title 21, Code of Federal Regulation (CFR), Section 803, 820, ISO 13485 and ISO14971. Communicates event investigation results via regulatory reports and written communications, as appropriate.Responsible for compliance with applicable corporate and divisional policies and procedures; review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations; serve as internal consultant on regulatory issues to Quality Engineers, and report decision-making in addition to writing, reviewing departmental Medical Device Reports (MDRs), MedWatch, Vigilance, MHLW and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. Apply codes and determine new coding on events to facilitate product performance records. Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
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Product Quality Analyst Abbott Medical OpticsAbbott Medical Optics, Inc. Jun 2013 - Nov 2015Abbott Park, Illinois, UsAnalyze and resolve Abbott product customers' technical and clinical questions regarding Abbott Corneal products. Correspond with customers regarding the results of inquiries and analysis of products. Uses discretion in escalating unusual product performance issues, collaborating with engineering and return goods lab to investigate and resolve customer complaints. Participate in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues. Possess a high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints. Interface with all levels of health care professionals (doctors, nurses, biomedical technicians and purchasing agents, materials managers and risk managers) to document, investigate, and correct field-related problems. Communicate customer concerns and complaints to individuals who manage databases and analyze data to identify trends, needs for product and service enhancements and communicate the findings with relevant individuals such as R&D engineers, business unit managers, and other personnel to communicate the findings. Serve as a liaison between other business units for quality and technical concerns as needed. -
Data Analyst / Abstractor Rancho Springs & Inland Valley Medical CentersUhs Feb 2013 - Apr 2013King Of Prussia, Pa, UsIdentify cases for review retrospectively, utilizing approved medical and hospital staff criteria/indicators. Network with the clinical area and Health Information Management to facilitate the process. Review paper and/or electronic medical charts for required documentation elements specific to the study being performed (Core Measures, focused studies, etc.) SCIP, HF, AMI, PN, Stroke, VTE, Immunizations, ED, and hospital outpatient program. Interpret and analyze the medical record documentation and extrapolate pertinent health information.Collect data from medical records, using pre-defined sets of measures and accurately enter data. Understand the interrelationship between performance improvement activities and those of other areas within the facility including clinical departments, infection control, risk management, health information, and the medical staff. Observe strict confidentiality of all information pertaining to quality assessment and improvement activities and practice discretion and sound professional judgment at all times. Remain current on measure specifications. Review QualityNet questions and answers on a regular basis. When specifications do not provide clear direction, submit clarifying questions to QualityNet. Identify opportunities for improvement (OFIs) when measures are not met. Prepare analysis report summarizing OFIs. -
Quality Outcomes AnalystSt. Joseph Hospital, St. Joseph Health Oct 2010 - Feb 2013UsRecordkeeping, designing, programming, and conducting searches/queries of Patient Relations records within the Peminic Incident Repoorting System. Generates reports from this database as requested. Back-up support for triaging, appropriate routing, and maintenance of Event Notifications. Generates searches/queries when requested. Conducts medical record review as assigned. Manages all patient relations compliments, complaints, grievances, suggestions and claims within the Peminic system. Ensures Managers follow up, investigate, and resolve all patient relations grievances in a timely manner.Serves as the Administrator of AVATAR database, including designing, programming, and custom report generation/data analysis, creation of dashboards and graphs of patient experience data. Back up Administrator of VSurvey / Verge database. Oversees record keeping, audit maintenance and creation, conducting reports/queries. Technical support to hospital staff. Provides data and analytical support to the Clinical Outcomes Analyst II in the creation of monthly dashboards for the hospital's Board of Trustees,Quality Committee of the Board of Trustees, Quality Council and Nursing Leadership Team.Provides system analysis for performance improvement databases. Conduct/create queries and reports to support the hospital's performance improvement programs. Function in a fast-paced environment with flexibility in prioritizing demands and large volumes of paperwork and computer input. Provide excellent customer service to managers and patients. -
Risk Management AnalystMission Hospital, St. Joseph Health Oct 2007 - Oct 2010Baton Rouge, Louisiana, UsPlans, prepares, and coordinates all information required for claims investigation and trial preparation including responding to all requests for production of documents and responding to both form and special interrogatories, scheduling and attending the interview process and depositions of all involved personell as needed and the sequestering of all pertinent evidence.Functions as a liaison to Corporate by completing and expediting the flow of all liability claim information including the Confidential Report to Attorney, Notice of Intent, Summons & Complaint, Medical Record and billing file retrieval. Works closely with health system defense attorneys and hospital staff on legal cases.Supports and collaborates with the QM Coordinator as directed in analyzing methods of improving organizational and risk management performance affording high quality patient care. Serves as a resource to hospital and medical staff for risk management. Accurately maintaines a database of event forms to generate statistical reports for tracking and trending of potential liability and system issues for medical, hospital, and administrative staff. Functions within department assisting with special projects as requested. Composes and types correspondence, memos, and statistical reports as directed. -
Executive AssistantSt. Joseph Hospital, St. Joseph Health Jan 2005 - Oct 2007UsRisk & Quality Management -
Program AssistantCaloptima 1997 - 2004Orange, California, UsMember Services Department and Healthy Families Program -
Administrative AssistantParacelsus Healthcare Corporation 1994 - 1996Charlotte, Nc, UsManaged Care Contracting Division -
Field Service Department SecretaryBaxter Healthcare 1990 - 1994Deerfield, Illinois, UsScientific Products Division -
Sales Department SecretaryProcter & Gamble 1986 - 1989Cincinnati, Ohio, UsHealth & Beauty Aids Department
Belinda Davis Skills
Belinda Davis Education Details
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University Of PhoenixHealth Administration
Frequently Asked Questions about Belinda Davis
What company does Belinda Davis work for?
Belinda Davis works for Abbott Cardiovascular
What is Belinda Davis's role at the current company?
Belinda Davis's current role is Analyst Product Performance Group.
What is Belinda Davis's email address?
Belinda Davis's email address is be****@****inc.com
What is Belinda Davis's direct phone number?
Belinda Davis's direct phone number is +146933*****
What schools did Belinda Davis attend?
Belinda Davis attended University Of Phoenix.
What are some of Belinda Davis's interests?
Belinda Davis has interest in Nfl And College Football, Lakers, Home Improvement, Co Ed Softball, Health, Children, Los Angeles Angels Of Anaheim, Education, Environment, Angels.
What skills is Belinda Davis known for?
Belinda Davis has skills like Writing, Snag It, Powerpoint, Work Well Independently, Close Attention To Detail, Sharepoint, Proofreading, Interrogatories, Insurance, Medicare, Risk Analytics, Chartmaxx.
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