• 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.
• 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.