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Mid-level QA title, strong employer brand, metro location, and 2–5 year experience increase competition.
High due to medical-device regulatory standards and domain-specific software quality requirements.
Explicit 2+ years plus mandatory regulated standards and quality processes make screening strict.
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Support software development teams to ensure software compliance with Illumina's policies and regulatory requirements (e.g., 21CFR820, ISO 13485, IEC 62304).
Execute software quality activities across assigned programs including review and approval of software development deliverables and participation in risk management and design reviews.
Support software quality issue resolution, process improvements, training delivery, audits, and software quality tasks related to emerging technologies (AI/ML, Cybersecurity, Cloud).
Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline.
Minimum 2 years experience in software quality engineering or related role in a regulated industry.
Working knowledge of relevant industry standards and regulations and basic understanding of SDLC processes.
Willingness to work shifts to support US region; occasional travel may be required; visa sponsorship not available.
Experienced in regulated software quality environments with solid understanding of quality systems and regulatory compliance.
Comfortable collaborating cross-functionally and supporting multiple software projects simultaneously in a fast-paced, dynamic environment.
Able to support continuous quality improvements and contribute to risk management and audit activities in a global delivery context.