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Tier-1 employer and Bangalore metro increase competition, but seniority and niche regulatory focus moderate applicant density.
Medical device regulatory and software design assurance expertise strongly limits cross-industry transferability.
Explicit 8-10 years plus mandatory SDLC, DFQ, defect management and regulatory expertise imply high filtering.
Develop, maintain, and manage comprehensive software quality documentation including SRS, ensuring compliance with standards and regulatory requirements throughout the software lifecycle.
Lead assessment of software designs verifying they meet quality, safety, and regulatory standards; conduct root cause analysis for quality issues and improve software design processes.
Oversee software quality plans and risk management activities lifecycle-wide; monitor software performance post-market and initiate corrective actions when necessary.
Bachelor's or Master's Degree in Computer Science, Computer Applications or equivalent.
8-10 years of experience in Software Quality Engineering or equivalent with Bachelor's/Master's degree.
Mandatory skills: Software Development Life Cycle (SDLC), Defect Management, Design for Quality (DFQ).
Office-based role requiring full-time presence at company facilities (minimum 3 days per week on-site).
Experienced in managing software quality in regulated environments ensuring compliance with global regulatory requirements and standards.
Proficient in applying root cause analysis, CAPA methodologies, and risk assessment to software quality and design validation.
Skilled in collaborating across teams to drive software quality improvements and mentor others in quality engineering and regulatory compliance.