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 v...
• 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 v...
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