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Software Quality Assurance Engineer

2 months ago


Oxfordshire, United Kingdom BioTalent Full time

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