• Develop and execute test strategies and plans aligned with project goals and timelines. • Lead functional, integration, regression, and performance testing to ensure reliable and high-quality software releases. • Identify, document, and manage defects while working with development teams to resolve issues efficiently. • Support and expand test automation efforts to improve testing efficiency and coverage. • Monitor quality metrics and communicate testing progress, risks, and outcomes to stakeholders. • Partner with DevOps and development teams to maintain stable test environments and effective test data management. • Identify opportunities to improve QA processes and implement best practices for software quality. • Mentor junior QA staff and contribute to building a collaborative, high-performing QA team.

• Responsible for creating the Design and Development Plan (DDP) for new development projects • Create and maintain risk management file with support from cross-functional teams include risk management plan/report, hazard analysis, dFMEA, uFMEA. • Provide mentorship, guidance and training to product development teams new to design controls and risk management processes. • Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications. • Manage deviation and issues for verification and validation activities. • Support design reviews and design transfer activities including process validations, pFMEA and DMR. • Support design changes and post market activities, ensuring product safety. • Perform risk assessments for regulatory submissions. • Participate in process improvement initiatives as necessary, performing gap analysis and risk communication.

• Lead the Design Controls planning and maintain the Design history file (DHF). • Ensure compliance with all applicable regulations. • Collaborate with cross-functional teams throughout the product lifecycle. • Support management reviews and audits related to Design Controls and Risk Management. • Create and maintain risk management file with support from cross-functional teams. • Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications. • Manage deviation and issues for verification and validation activities. • Support design reviews and transfer activities including process validations, pFMEA and DMR. • Perform risk assessments for regulatory submissions.

• Lead planning and execution of new product development and design change projects with a focus on Design Controls and Risk Management activities. • Work effectively with cross-functional teams for the harmonization and consistency across several projects. • Take ownership of the processes (Design Controls and Risk Management). • Identify improvement opportunities and lead cross-functional teams to implement the process improvements. • Provide mentorship, guidance, and training to the product development teams. • Support the implementation of eQMS tools for design controls and risk management (eDHF). • Lead Design Reviews with participation from the core teams. • Provide review and approvals of DHF deliverables such as verification and validation plan, protocol/report, requirements, and specifications. • Lead creation of risk management file with support from the cross-functional product development teams, risk management plan/report, hazard analysis, dFMEA, uFMEA. • Maintain risk file in the post-market lifecycle phase. • Support design transfer activities including BOM and DMR. • Assist in regulatory inspection readiness activities and provide support during regulatory site inspections. • Participate in process improvement initiatives as necessary, performing gap analysis. • Perform root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.