Intern - Quality Assurance & Regulatory Compliance

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 QMSR , 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.
• Ability to work independently as well as collaboratively within a team.

Location: Colombo, Foster Lane.