Ryan Jayne Email & Phone Number

Bend, Oregon, United States

Responsible for the preparation execution of validation protocols as well as the generation of their corresponding summary report. Conduct all work according to governing SOPs, GMPs, and in a safe and professional manner. Identify deviations from established product or process standards and provide recommendations for resolving deviations, including CAPA support. Prepare, maintain, or review validation and compliance documentation, such as engineering change controls, schematics, or protocols. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical manufacturing. Summarize Protocol execution and results for the IQ/OQ/PQ Summary Report. Perform Document/SOP Writing. Coordinate Validation Projects and ensure project timelines. Support Validation activities including generating User Requirements Specifications, System Impact Assessments, Risk Assessments, Data Integrity Assessments, Validation Master Plans, and Requirements Traceability. Participated in site audits as Validation SME. Offered continuous process improvements. Updated Site Validation Master Plan to reflect current corporate standards and company practices. Applies Good Manufacturing Principles in all areas of responsibility. Conducts all activities in a safe and efficient manner. Other duties performed as needed to meet business needs.

Eugene, Oregon

Leading team member of Verification and Validation Engineers for medical device install base (IB) development projects, providing leadership, direction and technical guidance to the team. Worked with cross-functional team during design inputs development phase to create system and software level requirements. Contributed to the generation of hazard and risk plans, analysis, and reports. Responsible for preparing documents for Verification and Validation including test plans, test protocols, requirements traceability matrix, project reviews, procedures, and V&V summary reports. Continued to manage the creation of test cases, and participated as a tester at the system, integration, and regression level. Provided input to service manuals and validated service documentation. Assisted with the design transfer process, including the creation of manufacturing procedures and forms. Member of the customer complaint handling unit to investigate and offer timely response and close of customer complaints. Assisted with CAPA analysis, planning, and reporting. Participant of Quality Audits, representing V&V for IB projects, as well as audit backroom contributor.

Eugene, Oregon Area

Organized and lead the Quality Assurance department, providing leadership, direction, and technical guidance, while managing all resource allocation, scheduling, inter-department communication (both local and remote), and hiring. Represented the Quality Assurance department to all other departments, and to executive management. Oraganized weekly Quality Meetings and Scrums and collected the meeting minutes for the QMS. Worked with the Regulatory department to assure compliance with all necessary standards, including ISO 13485:2016, EN ISO 14971:2012, IEC 62304:2006, and 21 CFR Part 820. This included making improvements to a number of the company's Quality Management System procedures, including the design process. Managed the requirements gathering, verification and validation of all company products, while ensuring adherence to the quality management system. Served as the sole requirements manager, monitoring and approving all requirements prior to sending them out for signature. Verified all requirements were written appropriately as engineering requirements, following internal and regulatory requirements. Administered the bug/issue, requirements, and test case management system, managing users, security groups, projects, defects, test cases, test runs, requirements, workflows, and automated progress report generation. Assisted in producing Design Outputs and in the Design Transfer process. Served as a high-level technical resource for the investigation and resolution of customer issues and complaints. Remained a hands-on contributor to the test team.

Eugene, Oregon Area

Software and hardware testing in conjunction with EEG research tools and other clinically related devices. Test development in compliance with design requirements and regulatory conditions, and following through with proper execution and documentation. General issue tracking. Collaborating with third party companies on design, testing, and troubleshooting. Effectively communicating and cooperating within and outside my immediate QA team to ensure proper methodology and creative solutions. Effort in centralized activities including Standard Operating Procedure and Software Requirements Specifications development.

Eugene, Oregon Area

Working with internally developed software for dEEG source analysis. Using high power computer nodes to solve complex physics calculations. Software testing, developmental design, and bug tracking. Prioritizing goals with software developer in China. Data organization and upkeep. Establishing training protocols. Collaborating on research projects and presentations with other researchers in-house and across the globe.

Eugene, Oregon Area

Data acquisition with dEEG 256 channel sensor nets on human subjects. Administering computer coded experiments in a carefully structured environment. Data analysis using Net Station and statistical tools. Working with company scientists to improve acquisition and analytical methods, as well as data presentation. Data entry, organization and backup across various servers and networks. Hardware (net) repairs. Training and mentoring of new Research Assistants. Authoring lab protocols and assisting with recruitment.