About this role
Work Flexibility: Hybrid
What you will do-
• Serve as the Quality representative on New 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 Medical Device Development process; New Product Development process and various phases of new product development; experience on Risk Management, different Risk Analysis tools and techniques and experience on ISO 14971 • Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001) and well versed with change control process • Experience in following technical areas is recommended - Software Development Life Cycle (SDLC); Risk Management / FMEA; Verification & Validation (V&V); Defect Management Systems (Jira, Azure DevOps, etc.); Requirements Traceability; Root Cause Analysis (RCA); Cybersecurity and Product Security concepts and change control process; 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.).
Preferred Skills-
• Should be ready to travel to divisions as required. • Effective interpersonal, communications skills. • Good understanding of Agile and traditional SDLC methodologies
Travel Percentage: 10%