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Tier-1 brand, metro location and mid-level generalist QA title increase applicant competition despite regulatory specialization.
Requires regulated medical-device quality and standards knowledge, making cross-industry transfers difficult.
Explicit 5+ years, regulatory standards and preferred certifications indicate strict domain-specific filtering of candidates.
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Own and execute software quality activities throughout the full Software Development Life Cycle for multiple products, ensuring compliance with company quality requirements, industry standards, and regulations.
Serve as the primary quality representative on cross-functional product teams, providing guidance on software development, verification, validation, risk management, and software lifecycle deliverables.
Drive continuous improvement in software quality processes, support internal/external audits, complaint investigations, CAPA activities, and deliver training on software quality best practices.
5+ years experience in software quality engineering or related role within a regulated industry.
Working knowledge of relevant standards and regulations such as IEC 62304, ISO 13485, and 21 CFR.
Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline.
Willingness to work shifts supporting US region; work location hybrid in Bengaluru, India; visa sponsorship not available.
Experienced in independently managing software quality activities in a fast-paced, global delivery environment with cross-functional teams across geographies.
Strong understanding of SDLC processes, software engineering best practices, and quality engineering principles including structured development and risk management.
Familiarity with cloud-based platforms, cybersecurity, AI-enabled capabilities, and regulatory compliance in medical device or life sciences software products.