John M. Koterba Email and Phone Number
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Certified Notary Public. Experience as Quality Analyst, Internal Auditor, Lower-level Manager, Tradeshow Coordinator and various positions with special duties and responsibilities. Especially well versed in process creation and improvement. Have shown exceptional aptitude for internal quality audits (specifically in regard to ISO 13485, FDA CRF Title 21:820, and HealthCanada). Although Quality Analyst is a vague description, duties range from financial decision-making to human resources, and, more broadly, sales to engineering. Responsible for FDA audit compliance among multiple international offices. Variety of interests included in five year personal plan include publication of a scholarly article, success as a healthcare administrator, various entertainment and arts projects and extensive volunteer work. Long term goals include publication as subject of a Forbes (or similar) article, recognition as an authority on Healthcare Administration Science, multiple post-graduate degrees, and educator.Specialties: -Bioethics-Excel, Powerpoint, and Visio applications-Healthcare Administration, Operations, and Process Improvement-Interdepartmental collaboration-Interoffice communication-Legal and Ethical implications-Pre-production testing (Alpha and Beta) -Publication and document creation and storage-Tradeshow coordination-Training-Trending of quality data
Dakota Software
View- Website:
- dakotasoft.com
- Employees:
- 65
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Qa AnalystDakota Software Dec 2014 - Present -
WriterSelf-Employed 2014 - PresentWhen not at my traditional position I enjoy writing novella-length fiction. I am currently working on a piece for inclusion in an anthology or periodical. My style is best described as a traditional American psychological and social commentary with elements of suspense, magical realism, and contemporary fantasy. I am always looking for and receptive to new readers, discovery and reflection. Requests to connect are always welcome.
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Quality AnalystMim Software Inc. Apr 2011 - Dec 2014Cleveland/Akron, Ohio AreaDuties included:-Performed annual quality audits as required by multiple international regulatory bodies including US FDA, EU CE Marking, HealthCanada and others.-Performed on-site Internal Quality Audits internationally (January 2014).-Revised quality system procedures to comply with ISO 13485: 2003.-Handled complaints assignment and coordinated investigations thereof totaling approximately 1,000 a year.-Coordinated functional tests throughout international offices (alpha testing).-Coordinated testing and communication between physicians and engineers (beta testing).-Compiled and cataloged legal documents (with guidance from in-house legal counsel).-Organized and ran meetings with engineers, operations personnel, and executive officers including but not limited to Quality Trends and Analysis, Project and Product Risk, and Design Review.-Managed efforts to receive clearance in countries throughout the world.-Coordinated domestic and international trade show logistics totaling approximately $600,000 worth of materials and planning.-Revised Trade Show process over 6 months to accommodate 300% growth of show volume in a 14 month period. -Created and implemented quality metrics and measurements.-Contributed to activities to improve operational efficiency.-Organized and maintained product history files for new and existing products.-Participated in risk analysis and mitigation for new products.-Researched various rules, regulations, approvals, clearances, and certifications.Certifications and Ongoing Training:-Certified Notary Public (August 2011 through August 2016)-Completed ISO 13485:2003, FDA Quality System Requirements; 21 CFR, Part 820, MDD/CE Mark and Health Canada (CMDR) Awareness Training (April 2012)-Completed Internal Auditor/Principles of Effective Auditing Awareness Training (April 2012)-Attended FDANews Annual FDA Inspections Summit (October 2013)-Learned basic SQL and database querying techniques (March 2014) -
Head CounselorKenston Middle School May 2007 - May 2014For one week in late May, I volunteer as a counselor serving special education students from Kenston Middle School. I have been identified by camp administration as the "go-to" counselor for students with acute to significant instances of autism, ADD, ADHD, and other special cases. I work with certified special education personnel to bring the fullest camp experience to these students. Often times, my time is manifested as one-on-one or small group activities with these individuals. While camp is only one week a year, the process to make it successful requires personal sacrifices over the course of a year. In addition to my work with the students I am responsible for mentoring other counselors, ranging in age from 18 to 24.
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Lead ServerHumility Of Mary Health Partners Aug 2009 - Apr 2011--Promoted to Lead Server in less than one year--Complied to HIPAA and Patient’s Bill of Rights--Carried out special tasks including catering activities and cleaning duty--Trained new employees--Hosted dining room--Initiated online schedule integration
John M. Koterba Skills
John M. Koterba Education Details
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Frequently Asked Questions about John M. Koterba
What company does John M. Koterba work for?
John M. Koterba works for Dakota Software
What is John M. Koterba's role at the current company?
John M. Koterba's current role is QA Analyst at Dakota Software.
What is John M. Koterba's email address?
John M. Koterba's email address is jm****@****ron.edu
What is John M. Koterba's direct phone number?
John M. Koterba's direct phone number is +144031*****
What schools did John M. Koterba attend?
John M. Koterba attended The University Of Akron.
What are some of John M. Koterba's interests?
John M. Koterba has interest in Applied Bioethics, Classic Films, Early American Literature, Yoga, Basketball, Nursing House And Hospice Administration.
What skills is John M. Koterba known for?
John M. Koterba has skills like Training, Customer Service, Powerpoint, Microsoft Excel, Process Improvement, Public Speaking, Microsoft Word, Event Planning, Testing, Visio, Healthcare, Social Networking.
Who are John M. Koterba's colleagues?
John M. Koterba's colleagues are Ashley Balazs, Nick Hull, Marc Robert, Leanne Triplett, Gabriel Arevalo, Laura Chiarelli, Julie Pecoraro.
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