#13277 - Validation testing

Position Overview: We are seeking a talented and detail-oriented Software Tool Validation Specialist to join our QualiTest team. The ideal candidate will be responsible for ensuring the compliance and effectiveness of software tools used in medical applications through rigorous validation processes. Responsibilities: · Develop and execute validation protocols, including test plans, test cases, and test scripts, for software tools used in medical devices or healthcare systems. · Collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs, and product management, to define validation requirements and ensure alignment with regulatory standards (e.g., FDA, ISO). · Conduct risk assessments to identify potential hazards and mitigate risks associated with software tool functionality and performance. · Perform verification and validation testing activities, including functional testing, integration testing, regression testing, and performance testing, to verify software tool requirements and specifications. · Document validation activities, findings, and test results in compliance with regulatory requirements and internal quality management systems. · Participate in design reviews, software development life cycle (SDLC) meetings, and change control processes to ensure validation considerations are addressed throughout the software development process. · Stay abreast of industry trends, regulatory changes, and best practices related…