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Mid-level role in metro Bangalore at a recognized medtech brand, but regulatory niche reduces applicant density.
Role requires regulated-medical software expertise and standards, limiting transferability across industries.
Explicit 5+ years in regulated software quality and mandatory regulatory standards create strict hiring filters.
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Lead software quality engineering activities for assigned projects, ensuring compliance with regulatory requirements (e.g., 21 CFR 820, ISO 13485, IEC 62304).
Own and deliver quality support across the software development lifecycle including review and approval of development and verification deliverables.
Collaborate with global cross-functional teams to align quality processes, drive software risk management, and support audits and continuous improvements.
Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline.
Minimum 5 years experience in software quality engineering or related role within a regulated industry.
Working knowledge of software development lifecycle (SDLC) and relevant industry standards (IEC 62304, ISO 13485, 21 CFR).
Ability to work in a global delivery model and occasionally work shifts supporting US time zones; no visa sponsorship provided.
Experienced in independently owning quality activities for software projects in regulated healthcare or biomedical domains.
Comfortable operating in fast-paced, cross-geography global teams with minimal supervision.
Familiar with quality engineering principles, risk management, regulatory audits, and driving continuous process improvements.