Kelley Myers
Conyers,GA
Summary
Skilled Post-Market Surveillance Consultant with in-depth knowledge at RQM+ Consulting, devoted to enforcing high regulatory compliance standards.
Overview
23
23
years of professional experience
Work History
Post-Market Surveillance Consultant
RQM+ Consulting
San Jose, USA
09.2021 - 11.2023
- Responsible for conducting post-market surveillance complaint activities and other remediation activities
- Ensure complaint meets department requirements prior to transferring complaint to the legal manufacturer for investigation
- Perform appropriate evaluation steps to ensure all available information is present so that COE team can determine reportability
- Determine product and incident complaint codes based on the master symptom code severity list
- Evaluate complaint files that have been identified as being filed late with the reporting agency for an Adverse Event
- Review intake source systems, complaint handling databases, and other systems to determine chain of events in the complaint process
- Coordinate the report assignments to ensure activities are completed in a timely manner and escalate issues to the appropriate department for resolution if required
- Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours while demonstrating the ability to communicate project risk and issues to the project lead in a timely fashion
Post Market Surveillance Consultant
EG Life Sciences
Andover, USA
03.2020 - 08.2021
- Responsible for; the review of bedside product complaint investigations, and corrective actions associated with product complaints in accordance with Corporate and Divisional policies and procedures, Quality System Regulations, and other regulatory requirements
- Review a summary of the investigation and analyzes adverse events, complaints, and problems that may be related to the device defect for Philips Healthcare bedside products; to include possible third-party manufacturer, the number of devices in use and the intended use of the product
- Review Service Work Order (SWO), Call Center, or other relevant documented service/customer input to ensure correct device and evaluation coding are within complaint processing compliance
- Determine product and incident complaint codes based on the master symptom code severity list
Field Assurance Specialist
Becton Dickinson
Covington, USA
07.2018 - 05.2020
- Coordinate the review, investigation, and corrective actions associated with product complaints with the manufacturing facilities responsible in accordance with Corporate and Divisional policies and procedures, Quality System Regulations, and other regulatory requirements to ensure that the duties of the department are performed in an accurate and timely manner
- Send device/product sample boxes and letters of correspondence to complainants to ensure samples are returned for evaluation
- Maintain timely complaint handling by ensuring no complaint is left in 'awaiting sample' state past 12 days
- Review and approve or reject field investigations processed on returned samples
- Perform final review for closure of complaint files to ensure accuracy, completeness, and attention to detail
Quality Engineer
Zimmer
Warsaw, USA
10.2016 - 08.2017
- Maintained high profile global orthopedic manufacturer records for Post Market Safety Surveillance for retrospective remediation of complaints
- Daily review of complaint documentation and attachments, to include engineer evaluations to determine FDA reportability as well as review of complaint files for final closure
Quality and Regulatory Compliance Consultant
Maetrics Consulting LLC
05.2013 - 08.2017
Recall Coordination Assistant - Phone Canvassing
Panoramic Corporation
Fort Wayne, USA
04.2016 - 05.2016
- Responsible for contacting two groups of Client customers, approximately 1,200, to gather sufficient information to bring the recall to closure
Quality and Regulatory Compliance Consultant
BioMérieux
Hazelwood, USA
11.2015 - 03.2016
- Prepare and submit all MedWatch Reports to the FDA in compliance with regulations, guidelines, and the required timeframe
- Receive and evaluate product complaints for FDA, EU, Canadian and other Health Regulatory Authorities as required for reporting requirements
- Maintain records from FDA Medical Device and International Vigilance Report investigations that are submitted
- Take responsibility for maintaining efficient Medical Device Report workflow and work assignments to achieve complete and timely closures
- Interface with internal and external customers to obtain additional information for complaint files and assure accuracy, integrity, completeness, and consistent content of all product complaint investigations and MDR and Vigilance reports
Recall Regulatory Specialist - Field Safety
Depuy Synthes (J&J)
West Chester, USA
04.2015 - 06.2015
- Coordinating and preparing document packages to notify regulatory agencies of Field Action monthly activities and updating internal recall binders
- Providing updates to FDA and act as support for FDA and regulatory inspections via 806.10c document
- Responsible for to field action recall request via depart inbox/incoming as well as answer hotline phone calls and performed effectiveness checks to assist in completion of open recalls
Post Market surveillance Complaint Handler/MDR Analyst
Depuy Synthes (J&J)
West Chester, USA
05.2013 - 03.2015
- Complaint Handling Unit (CHU) consultant responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions
- Assist with compliance quality remediation activities by reporting Initial and Supplemental MDRs
- Communicates with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues
- Responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure
- Responds to external questions regarding field actions
- Accountable for processing and closing complaints in a timely manner
- Maintain current knowledge of the FDA regulations
Legal Field Assurance Specialist
CR Bard
Covington, USA
09.2012 - 05.2013
- Create and send initial and supplemental Medical Device reports to FDA for product legal field assurance /Women’s Health complaints
- Determine whether a 30 day or 5-day MDR is required
- Maintain the records of all MDRs and document rationale for not filing MDRs
- Assess Summary & Chronology of Care for accuracy of complaint information, for a required MDR/Supplemental
- Assess MDRs for accurate patient information before FDA submission and contact outside manufacturer sources to include additional information in MDRs
- Evaluates complaints for determining MDR/events
- Process additional medical records received from hospital; lawyer etc
- For File Transfer Protocol sites (SLP and Prosar)
- Receive, review, and enter product complaint information into Complaint Management Database
- Determine and create Decision Trees (MDR & Investigations) based on information received from patients in complaints
- Ensure manufacturing sources are notified of all complaints received from products manufactured and complaint samples, when received, are forwarded to the manufacturing sources in a timely manner
- Perform final review for closure of complaint files and investigations to ensure accuracy, completeness, and attention to detail
- Generates response/acknowledgement letters to customers
Quality Assurance Analyst
Philips Healthcare
Alpharetta, USA
09.2011 - 08.2012
- Review Service Work Order (SWO), Call Center, or other relevant documented service/customer input to ensure feedback/ complaint process compliance
- Investigate & evaluate Service Work Order (SWO) in a prescribed time to establish 'Become Aware Date' for potential safety events
- Review a summary of the investigation and analyzes adverse events, complaints, and problems that may be related to the device defect for Philips Healthcare, Nuclear Medicine products and Ultrasound systems
- Review basic information for approximately 500 cases amongst a team of twelve quality assurance coordinators
- Review data such as the manufacturer, the number of devices in use, the intended use of the product
- Correctly code SWO with the aim of providing trending information necessary for product quality monitoring
- Ensure the correct translations (from local language into English) of SWO’s requiring further investigations by Business Units
- Assist and coach Customer Care Service Centers call coordinators, Field Service Engineers, and Application Specialists in awareness of potential safety events and accurate documentation of service work order events and activities
Data Standards Analyst
Foodbuy, LLC.
Alpharetta, USA
06.2010 - 09.2011
- Setup, implementation, and maintenance of distributor / manufacturer rebates and pricing while maintaining accurate and timely processing of discrepancy notices
- Present findings to management and solicit feedback via formal/informal communication while demonstrating a comprehensive understanding of contract term set and item attribute processes
- Ensure that all dealings with suppliers, clients, and internal personnel are carried out ethically and professionally
Service Delivery Manager/Billing Specialist
Radiant Systems, Inc.
Alpharetta, USA
08.2008 - 06.2010
- Review metrics throughout the month with Directors and Managers to proactively manage trends and service deliverables, Manage Items Log, and drive open items to time closure as well as the delivery of monthly and quarterly reports
- Research and respond to internal/external client escalations, also work with functional teams to deliver service in accordance with defined service levels
- Manage ongoing performance of employees including writing reviews and handling performance issues, work schedules, and serving as the first point of contact for routine people issues
Customer Service Coordinator
Siemens Healthcare
Atlanta, USA
02.2008 - 07.2008
- Order Entry, Order Tracking, Inventory Management, Coordination of Export Inspections, creation of export documents, providing shipping instructions to Freight Forwarder and basic management of documentary collections
- Participated in handling routine requests and provided international customer service, guidance, and export logistics support for products and/or programs through multi-warehouse distribution channels and identified problems as they occur and takes appropriate steps to solve them in exceptional situations
Service Specialist/Dispute Resolution Analyst
StorageTek Corporation/ Sun Microsystems
Norcross, USA
03.2001 - 02.2008
- Facilitated entire sales order/invoice creation process steps originated between Sales Representative and Order Coordinator (order entry, delivery confirmation, contract set-up, and billing)
- Resolved disputed billing items, responsible for claims resolution process; identify and resolve and/or recommend resolution of issues in order to reduce outstanding dollars in AR and customer deductions
- Contact customer and request and/or provide documentation as supports customer discrepancy resolution
- Notified management of customer deduction issues/problems and recommend solutions
Education
Bachelor of Science - Management
Shorter College
Skills
- Microsoft Office Suite
- Lotus Notes
- SAP ERP and Oracle applications
- Quality management systems
- AS400 and JD Edwards ERP
- Radar and Oasis platforms
- PeopleSoft ERP
- Trackwise system
- Sarbanes-Oxley compliance
- Six Sigma Yellow Belt certification
- Facilitation training
- Effective habits training
Timeline
Post-Market Surveillance Consultant
RQM+ Consulting
09.2021 - 11.2023
Post Market Surveillance Consultant
EG Life Sciences
03.2020 - 08.2021
Field Assurance Specialist
Becton Dickinson
07.2018 - 05.2020
Quality Engineer
Zimmer
10.2016 - 08.2017
Recall Coordination Assistant - Phone Canvassing
Panoramic Corporation
04.2016 - 05.2016
Quality and Regulatory Compliance Consultant
BioMérieux
11.2015 - 03.2016
Recall Regulatory Specialist - Field Safety
Depuy Synthes (J&J)
04.2015 - 06.2015
Quality and Regulatory Compliance Consultant
Maetrics Consulting LLC
05.2013 - 08.2017
Post Market surveillance Complaint Handler/MDR Analyst
Depuy Synthes (J&J)
05.2013 - 03.2015
Legal Field Assurance Specialist
CR Bard
09.2012 - 05.2013
Quality Assurance Analyst
Philips Healthcare
09.2011 - 08.2012
Data Standards Analyst
Foodbuy, LLC.
06.2010 - 09.2011
Service Delivery Manager/Billing Specialist
Radiant Systems, Inc.
08.2008 - 06.2010
Customer Service Coordinator
Siemens Healthcare
02.2008 - 07.2008
Service Specialist/Dispute Resolution Analyst
StorageTek Corporation/ Sun Microsystems
03.2001 - 02.2008
Bachelor of Science - Management
Shorter College
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