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Global brand and Bangalore metro presence increase competition, but medical-device regulatory specialization narrows applicant pool.
Medical-device regulatory and IEC 62304 expertise limits transferability across industries.
Mandatory 3–5 years plus IEC 62304 and regulatory medical-device quality requirements make filters strict.
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Maintain and ensure compliance of Software Requirement Specifications and quality documentation across software lifecycle.
Assess software designs against quality, safety, and regulatory standards; conduct root cause analysis and implement corrective actions.
Oversee software quality plans, risk management, and post-market analytics to monitor and improve software product quality.
Bachelor's degree in Computer Science, Computer Applications, or related field.
3-5 years' experience in Software Quality Engineering, Software R&D, or Software Testing.
Mandatory experience with IEC 62304/82304 standards.
Onsite presence required (minimum 3 days per week at office).
Experience in medical device software quality or R&D with strong regulatory compliance knowledge.
Proficient in quality engineering practices including root cause analysis, CAPA, risk assessment, and SDLC.
Familiarity with cybersecurity, AI in software quality, and design quality management in regulated environments.