About this role
Intern - Quality Assurance & Regulatory Compliance
Key Responsibilities:
- Execute firmware verification and functional testing of medical devices in accordance with IEC 62304 medical device software lifecycle requirements.
- Record test results and maintain accurate testing documentation according to regulatory standards.
- Identify, report, and track non-conformities and firmware defects.
- Support Quality Assurance and Regulatory Affairs activities in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
- Support internal audits and other quality-related activities as required.
Qualifications:
- Undergraduate or recent graduate in Biomedical Engineering, Electronics Engineering, Electrical Engineering, Physical Science, BioMedical Science, Biology or related field.
- Basic knowledge of embedded systems and firmware is preferred.
- Good analytical, troubleshooting, and problem-solving skills.
- Strong attention to detail and documentation skills.
- Willingness to learn medical device quality standards, including ISO 13485, ISO 14971 and IEC 62304.
- Ability to work independently as well as collaboratively within a team.
Location: Colombo, Foster Lane.