Major Duties
· Support software verification & validation (V&V) activities (test protocols, plans, reports), including non-product software assessment.
· Support product cybersecurity assessments in collaboration with cross-functional teams.
· Review software and system documentation to ensure quality and compliance.
· Maintain requirements traceability and support SDLC processes.
· Perform risk assessments (FMEA, hazard analysis) and drive issue resolution.
· Participate in sustaining engineering activities, including post-release support and issue resolution, may participate in design reviews and represent Quality in approvals.
· Support post-release changes, audits, and quality system improvements.
· Collaborate cross-functionally to ensure compliance with FDA, ISO 13485, IEC 62304.
Education and Experience:
· Minimum Bachelor’s degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.
· Minimum 2 years of experience in software quality, validation, systems engineering, or a related discipline.
· Experience working in a regulated industry (medical device, diagnostics, pharmaceutical).
· Self-motivated with the ability to work independently with minimal supervision. Strong analytical, communication, and teamwork skills.
· Experience in audit setting preferred.
Never miss an opportunity! Create an alert based on the job you applied for.
