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Tier-1 brand, mid-level experience band, and metro Bangalore location increase applicant competition.
Medical device regulatory QA skills (IEC 62304, regulatory compliance) are highly domain-specific and non-transferable.
Explicit 5-7 years plus mandatory medical device quality and IEC 62304 regulatory requirements raise filter strictness.
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Develop and maintain comprehensive software quality documentation, including Software Requirement Specifications compliant with industry standards and regulatory requirements.
Assess software designs and validate key design inputs such as usability, reliability, safety, and regulatory compliance throughout the software lifecycle.
Conduct root cause analysis for software quality issues and monitor post-market software performance, driving corrective actions to ensure product quality and compliance.
Bachelor's Degree in Computer Science or Computer Applications mandatory.
5-7 years of experience in Software Quality Engineering, Software R&D, or Software Testing required.
Experience with IEC 62304/82304 standards is mandatory.
Onsite presence required with office attendance at least 3 days per week.
5-8 years of experience specifically in medical device quality or R&D environments, indicating familiarity with regulated healthcare product standards.
Proficiency in regulatory compliance, risk assessment, root cause analysis, and quality management systems related to software design quality.
Experience in applying design quality management practices and utilizing software development lifecycle processes in a regulated environment.