Sr Software QA Engineer
Dexcom (company site, opens in a new tab)5–8 yrsBengaluruOn-siteDirect career pageEst. 12–20 LPA
Posted 1d ago
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Job description
Structured overview of role & requirements
About This Role
- Provide leadership and technical guidance on software quality assurance related to medical device software compliance with regulations like IEC 62304 and FDA 21 CFR 820.
- Lead continuous improvement and compliance activities for software development, validation, and risk management processes across software and cross-functional teams.
- Author, review, and approve technical documentation related to software design control and manage change control impact assessments to maintain product performance and compliance.
Minimum Requirements
- Bachelor's degree in a technical discipline required; experience varies with education (5-8 years with Bachelor's, 2-5 with Master's, 0-2 with PhD).
- Experience with software related to medical devices, including FDA 21 CFR Part 820, IEC 62304, ISO 13485 compliance.
- Experience in software quality or engineering covering requirements analysis, design/development, integration, and testing, including software mobile applications and web APIs.
- Work Experience Required: Typically 5-8 years related experience with Bachelor's, or less with advanced degrees. Notice period: Not explicitly mentioned in the JD.
Ideal Candidate Profile
- Experienced in medical device software quality assurance with strong knowledge of relevant regulatory standards like IEC 62304, FDA 21 CFR 820, and ISO 13485.
- Capable of leading cross-functional teams and driving software quality process improvements and compliance activities independently.
- Comfortable interpreting software design and code, communicating complex technical information to all levels of management, and managing documentation and risk assessments.