We are currently working on an Urgent position for a leading Medical Device company seeking a QA Software Engineer with 3+ years of SaMD experience with a strong knowledge of ISO 13485, ISO 60601 and IEC 62304 . The key responsibilities are as follows: Ensure the software meets all relevant regulatory requirements Alongside partners, prepare and maintain detailed documentation, including test plans, test cases, test scripts, and test reports. Lead the identification, assessment, and mitigation of software-related and cybersecurity risks, including those associated with the outsourced development and testing processes. Develop and maintain a risk management plan in accordance with relevant standards and frameworks, ensuring all identified risks are documented and mitigated effectively. Regularly review and update risk assessments to address any emerging risks during the software development lifecycle











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