Ramona Gonis
PRODUCT MONITORING MANAGER at NeuroPace- Claim this Profile
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English Native or bilingual proficiency
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ASL Elementary proficiency
Topline Score
Bio
LinkedIn User
Ramona is amazing. Ramona was a member of our departments leadership team and an extraordinary example of being driven and self motivated. On numerous occasions she was given an objective, to develop/implement a need, and with tenacity and focus, Ramona was able to bring the objective into a concrete set of actions and assignments. As important to the success of her work, while never seeming to struggle, Ramona would create forward momentum and bring the objective to a successful outcome. Ramona’s management of very large data sets set the standard within our function. Her organizational skills are exceptional and in conjunction with her work ethic, self motivation, and dedication, Ramona is able to provide a solid effort day in and day out. In summary, I highly recommend Ramona to any organization looking for a dedicated, accomplished, and very able team member.
Holly Gomes
Ramona Gonis is a valuable contributor to any team. She is a
LinkedIn User
Ramona is amazing. Ramona was a member of our departments leadership team and an extraordinary example of being driven and self motivated. On numerous occasions she was given an objective, to develop/implement a need, and with tenacity and focus, Ramona was able to bring the objective into a concrete set of actions and assignments. As important to the success of her work, while never seeming to struggle, Ramona would create forward momentum and bring the objective to a successful outcome. Ramona’s management of very large data sets set the standard within our function. Her organizational skills are exceptional and in conjunction with her work ethic, self motivation, and dedication, Ramona is able to provide a solid effort day in and day out. In summary, I highly recommend Ramona to any organization looking for a dedicated, accomplished, and very able team member.
Holly Gomes
Ramona Gonis is a valuable contributor to any team. She is a
LinkedIn User
Ramona is amazing. Ramona was a member of our departments leadership team and an extraordinary example of being driven and self motivated. On numerous occasions she was given an objective, to develop/implement a need, and with tenacity and focus, Ramona was able to bring the objective into a concrete set of actions and assignments. As important to the success of her work, while never seeming to struggle, Ramona would create forward momentum and bring the objective to a successful outcome. Ramona’s management of very large data sets set the standard within our function. Her organizational skills are exceptional and in conjunction with her work ethic, self motivation, and dedication, Ramona is able to provide a solid effort day in and day out. In summary, I highly recommend Ramona to any organization looking for a dedicated, accomplished, and very able team member.
Holly Gomes
Ramona Gonis is a valuable contributor to any team. She is a
LinkedIn User
Ramona is amazing. Ramona was a member of our departments leadership team and an extraordinary example of being driven and self motivated. On numerous occasions she was given an objective, to develop/implement a need, and with tenacity and focus, Ramona was able to bring the objective into a concrete set of actions and assignments. As important to the success of her work, while never seeming to struggle, Ramona would create forward momentum and bring the objective to a successful outcome. Ramona’s management of very large data sets set the standard within our function. Her organizational skills are exceptional and in conjunction with her work ethic, self motivation, and dedication, Ramona is able to provide a solid effort day in and day out. In summary, I highly recommend Ramona to any organization looking for a dedicated, accomplished, and very able team member.
Holly Gomes
Ramona Gonis is a valuable contributor to any team. She is a
Experience
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NeuroPace
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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PRODUCT MONITORING MANAGER
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Sep 2013 - Present
• Established electronic MDR process ( eSubmitter and ESG systems) • Established commercial complaint handling process. • Deliver timely and accurate data in support of Audits (FDA, TUV, Internal) • Establish Complaint Trending Reporting in support of QMS. • Perform training of personnel associated with the complaint handling system • Established electronic MDR process ( eSubmitter and ESG systems) • Established commercial complaint handling process. • Deliver timely and accurate data in support of Audits (FDA, TUV, Internal) • Establish Complaint Trending Reporting in support of QMS. • Perform training of personnel associated with the complaint handling system
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Manager, Product Monitoring
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Nov 2008 - Sep 2013
Manage the Product Monitoring Department data analysis team, data system processes and complaint trending for the Respiratory and Monitoring Solutions (RMS) division. • Remotely manage the operation of the Data Analysis Group including day to day functions, analyst oversight, and information dissemination. • Perform training of global personnel associated with the complaint handling system• Provide support of complaint processes for global manufacturing, servicing, and investigation facilities. • Deliver timely and accurate data in support of Audits (FDA, TUV, Internal)• Create, generate and distribute the Complaint Trending Reporting in support of QMS. • Administered the CAPA system.• Integrated four acquisitions into the complaint handling system. Show less
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QA Manager
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Nov 2008 - Sep 2013
Manage the Product Monitoring Department data analysis team, data system processes and complaint trending for the Respiratory and Monitoring Solutions (RMS) division. • Remotely manage the operation of the Data Analysis Group including day to day functions, analyst oversight, and information dissemination. • Perform training of global personnel associated with the complaint handling system• Provide support of complaint processes for global manufacturing, servicing, and investigation facilities. • Deliver timely and accurate data in support of Audits (FDA, TUV, Internal)• Create, generate and distribute the Complaint Trending Reporting in support of QMS. • Administered the CAPA system.• Integrated four acquisitions into the complaint handling system. Show less
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QA senior data analyst
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Nov 2005 - Nov 2008
Provide leadership (local and remote) for the RMS product complaint analysis and processes in support of Regulations and the Quality Management System.• Provided guidance and support to other QAAS (complaint handling system). administrators and to sites performing metrics using complaint data and the QAAS system.• Provided Audit Support - FDA/Certified Agencies/Corporate/Internal.• Generated the Monthly Product Complaint Report – site specific.• Administered the Complaint Tracking System.• Collaboration with Technical Service, Engineering, Failure Investigation teams, R&D, QA and Manufacturing personnel to develop queries in support of complaint product trending and analysis.• Provided guidance and support for all sites reporting Key Performance Metrics (KPI). Show less
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QA data analyst
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2004 - 2005
Provide data analysis on product performance based on complaint data analysis in support of FDA requirements and company quality policy.• Generated reports and charts based on failure code, product line, and lot/batch analysis Analyzed complaint data and charts for trends and outliers.• Generated complaint analysis summary reports in support of the QMS.• Performed Ad hoc complaint analysis to evaluate observed trends and outliers and provide support to other departments.• Created procedures defining complaint trending analysis. Show less
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quality supervisor
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2000 - 2004
Developed and Managed the TheraSense complaint handling unit. • Defined the software requirements and implemented electronic software for managing complaint cases electronically.• Defined, implemented and generated work instructions for the evaluation, investigation and receipt handling of customer complaints.• Generated standard operating procedures for evaluating, investigating and receiving customer complaints.• Defined and implemented a material handling area to receive product returns for the refund process, complaint investigations and non – deliverable items.• Performed internal auditing of the complaint area. Maintained a 99% or better reporting rate.• Performed tracking and trending utilizing information about production month, failure mode and complaint codes.• Implemented an electronic complaint handling system to document complaint investigations. Show less
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Microgenics
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Biotechnology Research
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1 - 100 Employee
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Complaint Handling & Manuf Chemist & supervisor
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1989 - 2000
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Education
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1983 - 1986
Washington State University
Bachelor of Science (BS), Microbiology, General -
Scuba Schools International
dive control specialist, SCUBA -
1977 - 1980
Cupertino High School
Community
