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Tier-1 employer and Bangalore metro raise competition, specialized medical-device skills limit applicant pool.
Regulatory medical-device expertise (IEC 62304, safety, CAPA) strongly limits cross-industry transferability.
Explicit 3–5 years plus mandatory IEC 62304 and regulatory requirements create strict shortlisting filters.
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Own the development and maintenance of software quality documentation and ensure compliance with relevant standards and regulatory requirements throughout the software lifecycle.
Assess software designs through review of test and performance data to ensure quality, safety, and regulatory compliance; conduct root cause analysis to resolve deficiencies.
Oversee execution of software quality plans and risk management activities, utilizing post-market analytics to monitor software performance and initiate corrective actions as needed.
Bachelor's Degree in Computer Science or Computer Applications required.
3-5 years of experience in Software Quality Engineering, Software R&D, or Software Testing.
Experience with IEC 62304/82304 standards mandatory.
Onsite presence required at least 3 days per week at company facilities.
Experience in medical device software quality or R&D preferred (3-5 years).
Familiarity with key software quality engineering practices such as root cause analysis, CAPA methodologies, regulatory compliance, and software lifecycle management.
Ability to manage software quality documentation, validation of design inputs, and communicate quality metrics aligned with business and regulatory needs.