
Software Quality Engineer – Medical Device Development
4 days ago
We are seeking a highly motivated Graduate Software Quality Assurance specialist to join our dynamic team. This is an excellent opportunity for a recent graduate to gain hands-on experience in a high-impact environment where software meets medical innovation.
About the Role- Develop software that complies with global medical device regulations, ensuring quality and reliability.
- Collaborate with experienced professionals on Design Control projects to achieve project goals.
- Contribute to the creation, review, and maintenance of Design History Files (DHF) / Technical Files, promoting regulatory compliance.
- Participate in risk management activities and design reviews to ensure project success.
- Document and support testing and validation of software at unit, integration, and system levels, utilizing industry standards.
- Navigate international standards and regulations, including ISO 13485, IEC 62304, and FDA guidance to ensure compliance.
- Collaborate with stakeholders to ensure projects meet regulatory and quality requirements, fostering effective communication.
- Recent Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or related discipline.
- Basic knowledge of software development and testing principles, with a strong foundation in programming languages.
- Desire to grow and learn about regulatory frameworks and best practices in medical device software development, staying up-to-date with industry trends.
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