• Provide quality oversight and support across all GCP, GLP, IND Enabling, and bioanalytical studies and programs. • Partner strategically with Clinical Operations and Nonclinical functions. • Oversee audit professionals/consultants for quality oversight of regulated study activities. • Explain quality standards to other functions as an SME and advisor. • Support internal and contracted organization activities. • Lead, direct, and advise continuous improvement of the department’s area of control.

• Own process quality across the product deployment lifecycle: site selection & audits → manufacturing/assembly → installation & commissioning → maintenance & monitoring, as well as human-in-the-loop operations • Develop and maintain process FEMAs, SOPs, installation checklists, and production and installation readiness gates that scale across regions and suppliers • Implement and operationalize KPIs & dashboards (e.g., first-pass yield, install success rate, MTTR) and use telemetry and ops data to detect process drift or systemic failures • Support root-cause investigations for process-related failures (incoming defects, installation errors, field incidents); own containment and durable corrective actions and verify effectiveness • Partner with human-in-the-loop operations: define QA for alert adjudication workflows, design audits for human review accuracy, and contribute quality requirements to tools and SOPs used by operators • Coach and enable field teams (installers, technicians, ops) with training, checklists, job aids, and feedback loops to continuously improve execution quality • Work cross-functionally with Operations, Hardware, Software, Customer Success to ensure traceability between process controls, system risks, and verification evidence.

• Coordinate testing efforts across multiple projects and squads • Act as the QA point-of-contact for product managers, developers, and other stakeholders • Create and maintain reusable testing documentation and workflows • Facilitate bug triage meetings and help prioritize QA focus areas • Support QA strategy implementation and process rollouts • Help bridge gaps between manual QA and automation efforts • Monitor QA metrics and provide insights to improve product quality and team efficiency • Collaborate with operations teams to streamline processes and ensure smooth releases

• Own end-to-end quality and mentor teams • Guide quality assurance across several Scrum teams • Participate in the full testing lifecycle — from test design to release validation • Design and maintain automated tests in TypeScript • Actively work with logs, metrics, and tracing tools to identify, reproduce, and debug issues • Design and execute load and performance tests using tools like k6 or JMeter • Validate APIs using Postman, Swagger, or custom scripts • Collaborate closely with developers, DevOps, and product managers • Contribute to DORA metrics improvement