Senior Developer / Lead - Validation & Verification

Key Responsibilities:

• Develop and maintain a Software Verification Plan (SVP) per IEC 62304, ensuring coverage of all required activities (unit, integration, system, acceptance).• Align verification activities with the organization’s Quality Management System (QMS) as required by ISO 13485, ensuring all SOPs, templates, and records are used and maintained.• Establish and maintain traceability between software requirements, risk controls, and verification tests.• Oversee creation and peer review of verification protocols, test cases, test scripts, and test data, ensuring direct traceability to software/system requirements and risk mitigations.• Ensure objective evidence (test records, logs, screen captures, defect reports) is generated and archived for every verification activity.• Maintain and update requirements to test traceability matrices throughout the project lifecycle.• Plan, schedule, and lead execution of all software verification activities from unit to system testing, with defined entry/exit criteria.• Ensure independence of verification from development (per IEC 62304) by not participating in core code development or reverse engineering.• Monitor and manage all defects/anomalies, ensuring correct documentation, classification, and tracking to closure.• Ensure re-testing and regression testing are performed after fixes, as required.• Ensure all verification deliverables (plans, protocols, reports) meet regulatory expectations and are prepared for internal/external audits and submissions.• Lead the generation of the Software Verification Summary Report (SVSR) and support the compilation of DHF/Technical File documentation as per ISO 13485.• Ensure all verification tools/environments are qualified and documented as per QMS.• Provide regular, transparent updates on verification status, risks, and blockers to project leadership and QA/RA teams.• Act as the subject matter expert during audits and inspections, presenting verification approach, evidence, and compliance rationale.• Facilitate verification review meetings and provide mentorship/training on the verification process to the test/QA team.• Collect and document lessons learned from verification cycles.• Recommend updates to QMS procedures/templates for improved compliance and efficiency.• Maintains process independence as required by IEC 62304 and ISO 13485.• All activities and records are always audit-ready and compliant with IEC 62304 and ISO 13485.• Ensures separation from core software development and design.• Maintains full bi-directional traceability from requirements to test evidence.• Maintains high standards of objectivity and quality focus throughout.• Escalates risks/issues early with impact assessment and solutions.