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Tier-2 brand, metro location, and mid-level generalist QA title increase applicant competition moderately despite medical-device niche.
Regulated medical-device software quality expertise and standards knowledge limit cross-industry transferability.
Explicit 2+ years requirement plus mandatory regulated-industry and standards knowledge increases filter strictness.
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Support software quality activities for assigned programs ensuring compliance with regulatory standards (e.g., 21 CFR 820, ISO 13485, IEC 62304).
Review and approve software development deliverables such as plans, requirements, test protocols, and risk documentation.
Participate in software risk management, design reviews, quality issue resolution, process improvement, and audit support.
Minimum 2 years experience in software quality engineering or related role within a regulated industry.
Working knowledge of software quality regulations and standards such as IEC 62304, ISO 13485, and 21 CFR.
Basic understanding of Software Development Life Cycle (SDLC) processes and software engineering best practices.
Bachelor's degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline.
Experienced in collaborative, cross-functional environments supporting software quality throughout the product lifecycle.
Capable of executing quality assurance tasks with guidance, including documentation and risk management in a regulated software development context.
Comfortable supporting new technology areas like AI/ML, cybersecurity, and cloud software systems.