David Pezet Email & Phone Number

* Research, develop and document technical design specifications.* Configure and maintain Confluence and Jira implementation.* Develop organization standards for Confluence documentation.* Develop Jira Workflows and maintain user documentation.* Set access permissions for Jira projects and Confluence spaces.* Install and manage apps/plugins for Jira and Confluence.* Communicate and share knowledge with internal and external contacts at all levels.* Determine needs of end users of technical documentation.* Gather usability feedback from all departments, including artists and production.* Organize and write supporting documentation for workflow processes to increase the user’s understanding and training.* Maintain documentation as new features or issues arise.* Work with others to improve the end-user experience and final documentation.

Gainesville, Fl

Quality & Regulatory Affairs• Develop & maintain QMS (ISO 13485 & FDA GMP).• Device registrations: FDA (510k) & Europe (CE/MDD).• Assist int'l registrations (Brazil, Korea, Thailand, Taiwan, etc).• FDA Establishment & Device Listings, Certificates to Foreign Governments.• US Dept. of State & int’l embassy document authentications/legalizations/apostilles.• Internal & regulatory audits (US FDA, EU NB, Korea kFDA).• Document & record control.• Supplier & product evaluations.• CAPAs.• Management review.• Assist in Risk Analysis, Clinical Evaluations & Post Market Surveillance reporting.• Monitor design lifecycle for hardware & software development.• Assist in device design & testing.• Labeling design (device, IFU, & UDI).• JIRA admin (custom fields, workflows, filters, add-on management, etc).• Confluence management (installs/updates, add-on evaluations, etc).Manufacturing• Implement & oversee processes.• Maintain inventory, equipment, & supplies.• Manage manufacturing & service/repair schedules.• Assist in design with consideration of manufacturing.• Assemble, label, package, & services according to instructions, diagrams, & BOMs.• Solder (IPC Specialist J-STD-001).• Power supplies, multi-meters, misc. electrical programming & test equipment.• In-process & final verification according to specifications.• Identification, segregation, report, analysis, & service of non-conforming products.• Maintain identification, traceability, & records.Regulations & Standards• ISO 13485, 14971• IEC 60601 (-1, -1-11, -2-26), 62366, 62304• EU Directive 93/42/EEC (Medical Device Directive) & MEDDEVs• US 21 CFR 820 Quality System Regulation (and associated)Software Experience:• Atlassian Confluence & JIRA (template & workflow design, .jsp & .vm customization, Scaffolding, Reporting, & misc. plugins)• Excel, Word, Power Point, Illustrator, Photoshop, Acrobat, Fishbowl, BarTender• Languages: Java, Python, Apache Groovy & Velocity Markup, SQL, Batch

* Developed and maintained the QMS to ISO 13485 and FDA GMP requirements. * Registered devices with FDA (510k) and Europe (CE/MDD).* Assisted in other international registrations.* Document authentication/legalization/apostille.* Internal & Regulatory audits (US, EU, Brazil) * Document and Record controls.* CAPA management.* Training.* Management Review.* Performed and assisted in the design of hardware and software testing. * Participated and monitored design and development processes. * Label design and instructions for use.* Assisted in marketing development.* Assisted in 60601-1 testing processes.

* Assisted in the development of the QMS to achieve ISO 13485 certification. * Assisted in registration of devices with FDA (510k), Europe (CE/MDD), and Brazil. * Participated in FDA, CE, and Brazilian audits. * Maintained QMS. * Performed hardware and software testing. * Participated in design and development processes. * Assisted in marketing and labeling development.