John Ashby Email & Phone Number

San Diego, CA, US

Irvine, California, United States

Hired to establish a new team of Scientists, Engineers, and Compliance specialists, responsible for the full organizational technical support and complaint handling process. The role includes building out a new infrastructure to address customer inquiries, technical complaints, and product investigations, including full CAPA management for all business.

South San Francisco, California, United States

• Hired to manage and develop the regulated infrastructure for the industry’s highest throughput COVID testing automation platform, leading the On-Market Support group responsible for all major service and support.
• Established an On-market Support team group responsible for all major service and support escalations on the industry’s highest throughput COVID testing automation platform essential to the global pandemic response.
• Developed and integrated systems combining Salesforce, Cloud for Service, SAP, JIRA to effectively capture escalated complaints ensuring efficient management, resolution, trending, and future sustaining.
• Led complaint investigations resulting in significant modification improvements to system hardware, software and organizational procedures. Close relations with R&D, field support and Product management; many affected.
• Implemented a regulated and compliant infrastructure to the organization, ready and in-preparation for 510K submission through training, team development, procedural, and cultural introduction.
• Reduced mean Investigation closure time from >90 days to <15 days, with significant 300% response time improvement. Introduced enhanced KPI and metric tracking processes.

Santa Clara, California, United States

• Established both a Service & Systems Integration team that took a complex new Medical Device technology through a successful 510K submission.
• Implemented Business process for System Integration planning, Call Management recording, Adverse Event recording and Issue Trending, which successfully passed an FDA 510K submission after previously obtaining multiple.
• Service team responsible for all internal and external service including Clinical Trials.
• Successfully secured justification and expanded the team size by >150% during tenure.
• Manage a laboratory Service & Integration team, responsible for all aspects of instrumentation from pre-launch development, thorough post launch Integration activities
• Oversees an audit ready laboratory environment, for instrumentation within a regulated diagnostic company competing in an IVD market.

Greater Chicago Area

• Lead a Global Service and Support group tasked with launching, integrating and supporting a primary ‘Next Generation’ medical device in an extensive global market.
• Direct, oversee and participates in the groups responsibilities, from Instrument development & launch through to Field Service Engineer development & on-going field support including Escalation Management.
• Assigns work activities, projects and programs; functioning with multiple groups including Vendors, QA, R&D, Finance, System Integration, Commercial & Software
• Reviews and evaluates work products, methods and all aspects of service procedures for a regulated diagnostic company competing in an IVD market.
• Responsible for Team Reviews, Performance Excellence and Development plans of the Global Service group.

Greater San Diego Area

• Established and led a Global Service and Support group tasked with supporting a Mass Spectrometry-based technology innovation in an IVD regulated market.
• Managed a cross-functional team comprising engineers, medical writers, training supervisors and senior scientists.
• Reduced Cost of Service by >5% through a strategy involving knowledge development, process consistency, proactive and predictive maintenance programs, parts and instrument management and refurbishment.
• Represented Division at numerous FDA audits.

Frankfurt Area, Germany

Assigned to the European branch of the company organization on a short term assignment, to establish and lead the Service & Support Operation with the roll out and implementation of new company technology at major Hospital shareholder sites through the EMEA territory.

Des Plaines, IL

• Short term assignment tasked with managing the Pre-staging operation of Diagnostic equipment.
• Leading a cross functional team, I led the project from concept to completion, successfully deploying over >20M$ worth of equipment, which upon completion saw a >35% increase in installation start up efficiency versus.

Greater Chicago Area

• Primarily responsible for ensuring a Global Field Service Organization is fully supported in multiple aspects of its role.
• Support responsibilities included establishing a Service & Support plan, multiple V&V testing, creation of full service documentation and service training curriculum and parts inventory management on a global scale.
• Functioned as a Service Project Lead in the launch of a new diagnostic instrument.
• Acted as a Project Manager for the pre-staging program of a newly developed diagnostic instrument.

London, United Kingdom

• Established and maintained a service infrastructure for the organization within the UK territory.
• As lead Engineer for the region, I was directly responsible for the upkeep of the full catalogue of Abbott molecular diagnostic units within the field of the EMEA region.
• Improved instrument reliability by modifying appropriate units and services documentation based on field observations, research and service feedback.

Crewe, United Kingdom

• Performed the dual role of an Application Specialist and Filed service Engineer working on SNP identification using dHPLC technology, responsible research and diagnostic work, in particular the identification of DNA.
• Responsible for installation, servicing and inventory management, as well as application roles involved customer training, data analysis and escalation support, along with summit leading.

Sheffield, United Kingdom

• Creating new and modifying existing applications on the Transgeomic WAVE dHPLC system
• Participated in the design and implementation of Bacterial Two-Hybrid System, and the development of a Fluorescently labeled DNA detection system.
• Specialized in projects involving peptide synthesis, DNA synthesis, DNA sequencing and protein sequencing

Bsc Honours, Biosciences & Health

Bachelor Of Technology (Btech), Molecular Biology

Associate'S Degree, Business/Commerce, General