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