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