Software Design Assurance Quality Engineer
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Job Description
Structured overview of role & requirementsAbout This Role
Manage software quality documentation including Software Requirement Specifications (SRS) ensuring compliance with standards and regulations throughout the software lifecycle.
Lead software design assessments and root cause analysis to ensure quality, safety, and regulatory compliance, embedding quality within software design.
Oversee software quality plans execution, monitor post-market software performance, and initiate corrective actions to maintain software quality standards.
Minimum Requirements
Bachelor's/Master's Degree in Computer Science, Computer Applications or equivalent.
6-7 years of experience in Software Quality Engineering or equivalent.
Mandatory knowledge of Software Development Life Cycle (SDLC), Defect Management, and Design for Quality (DFQ).
Full-time onsite work presence in company’s facilities (Office role, at least 3 days per week).
Ideal Candidate Profile
Experienced in health technology or health IT domains with strong regulatory and quality compliance knowledge.
Proficient in root cause analysis, CAPA methodologies, risk assessment, and continuous improvement within software quality processes.
Ability to act as subject matter expert providing guidance on quality engineering practices, regulatory compliance, and software quality metrics management.