Senior Advance Quality Engineer

Overview

Serve as the Quality representative on New Product Development and sustenance engineering projects for SaMD and non-medical software. Drive software quality, compliance, verification, validation and risk-management activities across the development lifecycle.

What you'll do

• Serve as the Quality representative on New Product Development (NPD) and sustenance engineering projects.
• Define quality and compliance requirements for development of SaMD and ensure requirements are communicated to stakeholders and met.
• Develop processes and procedures for development, testing and deployment of SaMD or non-medical software.
• Ensure software development activities comply with established SDLC processes.
• Participate in requirements, architecture, design, code, verification and validation reviews.
• Drive risk-management activities, including software hazard analysis and FMEA reviews.
• Review and approve quality deliverables throughout the development lifecycle.
• Ensure requirements for traceability, completeness and testability, as well as end-to-end 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, including ISO 13485, FDA regulations, IEC 62304, cybersecurity requirements and company quality procedures.
• Support internal and external audits.
• Ensure software bugs in pre-production and production are properly addressed.
• Review CAPAs, non-conformances, deviations and change controls related to software products.
• Validate software tools used in development, testing and deployment.
• Ensure deployment compliance per customer requirements in collaboration with R&D and deployment teams.
• Maintain the Design History File (DHF) and software quality documentation.
• Partner with Software Engineering, Systems Engineering, Product Management, Regulatory Affairs, Clinical Affairs and Manufacturing teams.
• Provide guidance on software quality best practices.
• Mentor junior quality engineers and support organizational capability building.

What you'll need

• Experience with the Medical Device Development process, the New Product Development process and various phases of new product development.
• Experience with risk management, different risk-analysis tools and techniques, and ISO 14971.
• Understanding of Quality Management Systems, including ISO 13485, 21 CFR 820 and ISO 9001.
• Be well versed with the change-control process.
• Experience in Software Development Life Cycle (SDLC).
• Experience in Risk Management / FMEA.
• Experience in Verification & Validation (V&V).
• Experience with Defect Management Systems such as Jira and Azure DevOps.
• Experience with Requirements Traceability.
• Experience with Root Cause Analysis (RCA).
• Experience with Cybersecurity and Product Security concepts.
• Experience with change-control process.
• Experience with Jira, Testrail, TrackWise, Salesforce and Slack.
• Bachelor's degree in Computer Science, Software Engineering, Electronics Engineering, Biomedical Engineering or a related discipline.
• 5 years-7 years of experience, including 4 years in relevant Software Quality Assurance, Software Engineering or Quality Engineering.
• Experience working in regulated environments such as Medical Devices, Healthcare Software, Automotive or Aerospace.

Nice to have

• Master's degree.
• Effective interpersonal and communications skills.
• Good understanding of Agile and traditional SDLC methodologies.

Details

• Work mode: Hybrid.
• Location: Gurugram, India.
• Should be ready to travel to divisions as required.
• Travel percentage: 10%.