Job Description
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.
