Serve as the Quality representative on Current 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; Develop and execute software quality strategies, test plans, and validation approaches.
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
Experience on Medical Device Development process; experience on Risk Management, different Risk Analysis tools and techniques and experience on ISO 14971
Understanding of Quality Management Systems. (Experience in following technical areas is recommended - Software Development Life Cycle (SDLC); Risk Management / FMEA; Defect Management Systems (Jira, Azure DevOps, etc.); Root Cause Analysis (RCA); Jira, Testrail, TrackWise, Salesforce, slack
Education- Bachelor's degree in Computer Science, Software Engineering, Electronics Engineering, Biomedical Engineering, or related discipline/ Master's degree preferred
Experience- 5 years- 7 years; 4 years in relevant Software Quality Assurance, Software Engineering, or Quality Engineering.
Experience working in regulated environments (Medical Devices, Healthcare Software, Automotive, Aerospace, etc.).

Should be ready to travel to divisions as required.
Good understanding of Agile and traditional SDLC methodologies

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes.

📌 Senior Quality Engineer - Electronics (Gurugram)
🏢 Stryker
📍 Gurugram