QMS Architect | Innovation-Ready Quality Systems

In his current role, Joshua manages the design quality function at DNAe in developing a sequencing-based IVD platform. The team, Joshua and his direct reports, are responsible for structured development and risk management across assay reagents, cartridge assembly, hardware and software.

On 09 December 2025, DNA Electronics Inc. was awarded ISO 13485:2016 certification (Certificate No. MD 806449) by British Standards Institution. The dual-site certification covers operations in Carlsbad, CA, USA and London, United Kingdom.

Joshua led the architectural design and implementation of the QMS supporting product realization across both sites. The system was structured around modular process activities with embedded requirements, built-in verification controls, and integrated risk management. During the audit, assessors highlighted not only the effectiveness of the QMS, but also the clear and traceable flow of information from product requirements to device specifications through a robust risk management framework.

Joshua architected a system that refined design input requirements and aligned them with both identified hazards, such as arcing and chemical risks, and use scenarios, such as input patient samples. Breaking down the requirements clarified the expectations for each system unit within the system architecture.

He then developed a traceability framework linking the system architecture to product requirements, using design FMEA to verify that risk controls were correctly implemented. Design elements were revised if mitigations did not fully address requirements. Piloting the processes on assay reagents and Printed Circuit Board assemblies confirmed the approach worked effectively.

At Cue Health, Joshua helped transition an at-home COVID molecular test from EUA to full FDA approval. Previously, design verification focused primarily on the assay itself. Joshua introduced structure to the process, aligning verification with both design inputs and use scenarios, such as storing the product in the fridge or under direct sunlight.

Hazard analysis guided additional flex studies ensuring the product performed safely under at-home conditions. The device’s in-system controls prevented issues, but the structured process provided the FDA confidence needed for regulatory approval.

This approach created a repeatable design verification framework that closed documentation gaps and enabled faster, more reliable verification of subsequent medical devices.

Problem: After expanding the manufacturing fleet for lyophilized reagent pellets, cartridge reject rates increased significantly.

Investigation: Joshua led a root cause analysis, identifying gaps between the independently managed design FMEA (dFMEA) and process FMEA (pFMEA). Mitigations for component interactions and process execution beyond controlled input parameters were missing.

Correction: He collaborated with the team to implement a QC test for the pellets and ensured alignment between design intent and process controls.

Corrective Action: Joshua restructured the FMEA alignment so that all critical design characteristics defined in the dFMEA were adequately represented with corresponding detection controls in the pFMEA. This linked design intent directly to process validation.

Effectiveness Check: Cartridge failures were reversed, and a repeatable, traceable process was established for preventing design transfer failures.