Principal Software Quality Engineer

Responsibilities:• Build, maintain and manage quality management system• Monitor all product software design, development, verification and validation (V&V) activities to ensure that software is implemented in accordance with established regulatory and company requirements and that the process is carried out in accordance with established procedures.• Participate and review the development plans to ensure full project scoping and assessing the impact on work products due to the planned changes.• Participate in the review of user-level product requirements, software requirements, functional requirements, software architecture and detailed design.• Generate software risk management by utilizing techniques such as Software Fault Tree Analysis and Software FMEAs.• Participate in the reviews of software test plans and protocols, traceability and automated scripts for ensuing full test coverage. Recommending strategies and methods to improve test plans and test processes.• Review and analyze the test data & reports for documented verification and validation evidence.
Must Have• Bachelor’s Degree in Engineering, Technical or Scientific field and 7+ years of quality• Experience working in the medical devices/ Digital Health field• Strong working knowledge of quality systems and quality assurance processes with a focus on software development and/or V&V activities.• Hands on knowledge of design controls and risk management (system risk analysis and SW FMEA)• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
Nice to Have• Master’s Degree in Engineering, Quality, Regulatory, or related.• Previous direct experience in software development and/or software test.