• Audit Governance (Internal, External & Client Audits) • Develop and maintain governance dashboards and KPI packages for audits, CAPA, deviations, suppliers, and commitments. • Own the Quality Audit Program including risk‑based planning, execution, reporting, and post‑audit governance activities. • Lead all internal audits, ensuring audit scopes, tools, documentation, and reports meet QMS and regulatory requirements. • Act as the primary QA lead during external and client audits, managing readiness, evidence compilation, SME coordination, and audit execution. • Document audit observations with objective, risk‑aligned language and ensure timely, high‑quality responses. • Govern the closure of audit‑related action plans and CAPAs, verifying effectiveness, sustainability, and escalation of risks. • Maintain audit governance documentation, schedules, templates, and systemic trend analyses. • Oversee CAPA and action‑plan governance ensuring problem statements, RCAs, risk scoring, and actions meet quality standards. • Review CAPA packages for clarity, completeness, effectiveness, and sustainability. • Track CAPA timeliness, effectiveness checks, recurrence trends, and escalate systemic issues. • Lead supplier qualification and re‑qualification including risk tiering, documentation review, and assessments. • Govern supplier performance monitoring, issue escalation, and remediation planning. • Collaborate closely with Procurement, Operations, Clinical, and Pharmacy teams to manage supplier risks. • Develop, review, negotiate, and maintain Quality Agreements with clients and suppliers. • Track contractual quality commitments, deliverables, and evidence required for audits. • Provide guidance to teams regarding Quality Agreement interpretation and obligations. • Analyze trends to identify risks and systemic improvement opportunities. • Present concise governance insights to leadership, clients, and cross‑functional teams. • Ensure data accuracy, traceability, and integrity in governance systems. • Serve as a key QA Governance contact for clients, suppliers, and internal partners. • Support client governance meetings with reporting, metrics, audit updates, and quality insights. • Lead communications on externally reportable issues and risks to service continuity. • Lead and coach the QA Governance team, managing workload, performance, and skill development. • Provides clear direction, sets measurable goals, and holds team members accountable for performance and results. • Coaches, develops, and supports team members through regular feedback, performance reviews, and career development planning. • Fosters a high-performing, inclusive team culture that aligns with company values and business objectives. Act as back‑up for the Manager, QA Governance for escalations, governance decisions, and external interactions.

• Leading software assurance activities throughout medical device software life cycle • Creating software quality assurance plan • Determining software safety classification • Software test readiness and software release readiness • Ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing • Being an active member of the software team during the whole software life cycle • Responsibility for physical and functional configuration audits • Reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results • Providing insight to management regarding software project status and software quality metrics • Ensuring compliance with applicable regulatory requirements and industry standards • Performing gap assessments • Immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements • Acting as a quality champion in software product development and testing teams • Supporting other software related processes such as CAPA process and other quality related processes regarding cybersecurity risk management and software quality assurance.

• Lead quality assurance activities portfolio wide • Establishing and executing a comprehensive test strategy • Performing functional, regression, and integration testing • Managing defect tracking and enforce quality gates prior to release • Standardizing Documentation • Supporting audit and compliance requirements • Reducing production defects and incident volumes • Supporting Future Modernization Initiatives

• Test SEPA credit transfer flows, SWIFT MT / ISO 20022 message flows, and Visa card payment flows including 3DS2 authentication. • Perform API , contract, schema, and integration testing at the microservice layer, including async / event-driven workflow testing across queues, retries, and DLQ. • Execute structured test scenarios across SEPA , SWIFT , and Visa payment workstreams and validate end-to-end transaction lifecycle flows, reconciliation, settlement, and data consistency. • Conduct resilience testing including retries , circuit breakers , DLQ , failover, and idempotency validation, as well as performance, load, and stress testing for platform stability. • Develop, execute, and integrate automated test suites into CI/CD pipelines. • Produce audit-grade test evidence and traceability documentation for PCI DSS compliance. • Validate web, mobile, and cross-platform functional consistency and regression coverage. • Collaborate with developers, DevOps , and security teams to identify, track, and verify defect resolution.