Savannah Arthur, Mba Email and Phone Number
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Working with cross-functional teams and collaborating with various departments, such as operations, QA, R&D, engineering, and sustaining engineering, I have introduced new processes that positively impacted and improved the manufacturing of medical devices that help patients worldwide.I work on concurrent projects and enjoy fast-paced environments. At Cook Medical, I work in a regulatory environment. Before Cook, my experience includes working on-site at customers' laboratories installing, troubleshooting, and maintaining chemistry instruments.My 4-year product development project I am proud of involved researching, inventing, and manufacturing a chemical-free water purification system that can help people across the globe. HIGHLIGHTS:▶ RESEARCH, ANALYSIS & PROCESS IMPROVEMENTS — Throughout my years studying biochemistry and biology, I conducted scientific research and analyzed data continuously. My interest in improving processes and products carries on as a production engineer. I plan on using these skills throughout my career. ▶ Training — I developed and honed my training skills as I supervised 20+ employees at UPS and was selected to train 96 UPS centers across the globe on a technical operations software system. I have trained manufacturing operators on processes, compliance, and standard operating procedures. I also conducted training with groups and one-to-one with customers using laboratory equipment.▶ Documentation, Reporting & Technology — My research and lab experiences laid the foundation for being detailed-oriented for accurate documentation. I understand reporting, compliance, and regulatory affairs and how correct records play an important role for businesses. I have strong technical skills from selecting and using a broad range of systems and training employees.▶ Project Management — From UPS to Cook Medical, I have managed and been part of teams improving processes and products to reach customer needs and business goals. I have worked in all project management phases, independently and with groups, from concept to completion. Happy to connect on LinkedIn.
Cook Medical
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Regulatory Affairs Specialist 2Cook Medical Oct 2024 - PresentBloomington, Indiana, Us• Team Lead on RIMS• Team Lead on EUDAMED• Team Lead on EUMDR• EUMDR Implementation • EUMDR IMDRF Format Maintenance • MDD / STEAD Format Maintenance• IMDRF MAP Building• UK• Switzerland
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Regulatory Affairs SpecialistCook Medical Feb 2021 - PresentBloomington, Indiana, UsCompliance, License Submissions, Communication Liaison and market medical device products worldwide. Support and implement software Product Lifecycle Management (PLM) into the department for all reports, IFU labels, and documentation supported. Communicate in various countries to obtain licensing submissions, documentation, etc. for renewing and future submissions. Maintain Compliance with EUMDR Regulations and Tech Files to ensure the patient safety and effectiveness of the device is met in accordance to FDA regulations.SME-IMDRF EUMDR FormatSME-STEAD MDD / EUMDR FormatSME-EUMDR Implementation and Maintenance•Met goal of overall project of MAP building ( 7 of 7) on time with no gaps•Met goal of turnaround time of 30 days or less completion time for all CMEU deficiencies for all 7 files •Met goal of turnaround time of 30 days or less completion time for TUV deficiencies for all 7 files•Successfully met goal of obtaining MDD extension letter requests prior to the certificate date expiration•Obtained the G11 Certificate within the 3 month timeline of successfully passing our audit with no findings•Met goal of <95% for the year of deliverables for all RA documents in the MAP building •Successfully constructed and executed an MDR Implementation and MAP maintenance plan within a 2 week timeline of our new product launch to market.•Launched 1 brand new development product successfully under MDR in the EU and met all department project deadlines across the board within a year.•Completed and written all 6 post market surveillance plans and reports on time according to the clinical schedule •Team Lead success in training HCL contractors in meetings, presentations, questions, and completion of job performance reviews.Software Systems• Regulatory Intelligence Management System (RIMS)• Product Lifecycle Management (PLM)• Global Approval and Restriction System (GARS)• Global Product File (GPF)• European Database on Medical Devices (EUDAMED)
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Production EngineerCook Medical Feb 2020 - Feb 2021Bloomington, Indiana, UsPlan, create, coordinate, and implement manufacturing processes for medical device products. Support operations and ensure methods produce quality products within engineering specifications and time. Work and build relationships with multidisciplinary teams, vendors, and departments: operations, QA, R&D, engineering, and regulatory affairs to improve product designs and processes. Presented to groups and serve as a resource for operational departments providing materials and equipment/processes upgrades. Worked with management on project timelines and justifications.● Recognized by management for saving $1.3M with co-engineer; co-led remediation project and implemented tools and validation processes that delivered savings.— Exceeded remediating project goal 40%, completing 14 product families with hundreds of related goods; partnered with research and design (R&D) team on projects to eliminate future production challenges.Conducted research and recommended software for improved tooling, which increased operator efficiency and eliminating steps in production; prepared and maintained all documentation.Collaborated with co-worker throughout project to exceed goals, document, meet compliance with FDA and other legal requirements; followed quality system procedures, and verified/validated processes and products.Developed, implemented, and trained operators on new production processes; assisted with transition of product modification from development state to production environments.
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Technical Support And Field Application SpecialistCarolina Liquid Chemistries Corp. Jun 2019 - Jan 2020Greensboro, North Carolina, UsInstalled, conducted troubleshooting, and maintained instrumentation on-site at customer laboratories. Created validation materials for drugs and linearity for toxicology. Built relationships, interfaced with customers, and participated in meetings. Maintained working log detailing all documented calls related to hardware and software application problems. Handled customer complaints and investigated to resolve issues and ensure compliance● Reduced hotline calls by increasing educational training with customers at facility; shared technical knowledge on analyzers, qualitative tests, wavelength calculations, CLIA compliance, chemistry testing, and quantitative testing.● Engaged with customers and strengthened relationships, providing training on analyzers, technical support on innovative products, and scientific-based design and development knowledge.● Contributed to developing technical support plans and new products to ensure successful launch and support of implementing new technologies, products, processes, and customer support. -
Operations Supervisor/ Package DispatchUps May 2014 - May 2019Atlanta, Ga, UsPromoted to supervisor at young age and led team of 20 warehouse employees. Gained respect of team and eliminated challenges with union workers/contracts by modeling best practices, assisting team, and training employees. Planned, executed, and documented safety and training plans to meet compliance. Analyzed data, developed improvement plans, and executed to meet business goals. Built and maintained relationships with internal and external stakeholders. ● Trained 96 UPS centers worldwide on technical operations software system; sought out by corporate leaders to conduct training on system with calculation analysis due to communications, leadership, and technical skills.● Reduced safety injuries 35%+ in 2019 by facilitating meetings and proactively incorporating safety training, reminders, and tips during morning communications meetings with new and existing employees.● Decreased address corrections 50%, which improved efficiency and productivity; trained team to correct and add addresses into systems to ensure future matching and increase in speed of processing packages.
Savannah Arthur, Mba Skills
Savannah Arthur, Mba Education Details
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Western Governors UniversityHealth/Health Care Administration/Management -
Ohio Valley UniversityBiochemistry And Molecular Biology
Frequently Asked Questions about Savannah Arthur, Mba
What company does Savannah Arthur, Mba work for?
Savannah Arthur, Mba works for Cook Medical
What is Savannah Arthur, Mba's role at the current company?
Savannah Arthur, Mba's current role is Regulatory Affairs Specialist II | EUMDR ▶ MDD ▶ Scientist ▶ Research & Analysis ▶ Improving products through cross-collaboration, process improvements, and modern technology..
What is Savannah Arthur, Mba's email address?
Savannah Arthur, Mba's email address is sn****@****ail.com
What schools did Savannah Arthur, Mba attend?
Savannah Arthur, Mba attended Western Governors University, Ohio Valley University.
What skills is Savannah Arthur, Mba known for?
Savannah Arthur, Mba has skills like Chromatography, Endospore Staining, Sterile Technique, Electrolysis, Microsoft Word, Microsoft Excel, Being Assertive, Team Leader, Thinking Outside The Box, Proactive Monitoring, Strategic Planning, Resourceful.
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