John M. Koterba Email & Phone Number

When 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.

Cleveland/Akron, Ohio Area

Duties 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)

For 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.

--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