Work Flexibility: Hybrid

What you will do-

• Serve as the Quality representative on Recent Product Development (NPD) and sustenance engineering projects.
• Defining the quality and compliance requirements for development of SaMD and ensuring the requirements are communicated to the stakeholders and met.
• Development of process and procedures for development, testing and deployment of SaMD or Non Med SW and ensure software development activities comply with established SDLC processes.
• Participate in requirements, architecture, design, code, verification, and validation reviews and drive risk management activities including software hazard analysis and FMEA reviews.
• Review and Approve quality deliverables required throughout the development lifecycle; requirements for traceability, completeness, and testability and E2E test coverage and compliance.
• Develop and execute software quality strategies, test plans, and validation approaches.
• Ensure appropriate verification and validation activities are performed and documented.




• Ensure compliance with industry standards and regulations (e.g., ISO 13485, FDA regulations, IEC 62304, cybersecurity requirements, company quality procedures).
• Support internal and external audits and ensure the SW bugs (pro-prod and prod) and properly addressed and review CAPAs, non-conformances, deviations, and change controls related to software products.
• Validation of SW tools used in development, testing and deployment.
• Ensuring the deployment compliance per customer requirements in collaboration with R&D; and deployment teams.
• Maintain Design History File (DHF) and software quality documentation
• Partner with Software Engineering, Systems Engineering, Product Management, Regulatory Affairs, Clinical Affairs, and Manufacturing teams and provide guidance on software quality best practices.
• Mentor junior quality engineers and support organizational capability building

What you will need-

Required Skills-

• Experience on Medi

📌 Senior Advance Quality Engineer (Gurugram)
🏢 Stryker
📍 Gurugram