- 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. (ISOCRF 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- Bachelors degree in Computer Science Software Engineering Electronics Engineering Biomedical Engineering or related discipline/ Masters 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.
- Valuable understanding of Agile and traditional SDLC methodologies