Senior Advanced Quality Engineer - Medical Device Software

Stryker India Private Limited; Gurugram District; Hybrid; INR 3,000,000 - 4,500,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Stryker India Private Limited seeks a Senior Advance Quality Engineer to lead software quality on NPD and sustainment for SaMD and related healthcare software. You will define quality requirements, ensure SDLC compliance, and drive risk management activities. This role partners with Regulatory, R&D, and Deployment teams and mentors junior engineers.

Hybrid work arrangement with travel up to 10% may be required. Strong experience in ISO 13485, IEC 62304, and cybersecurity concepts is preferred.

Qualifications

• 5–7 years in software quality assurance/engineering.
• Experience in regulated environments (Medical Devices, healthcare software).
• Strong knowledge of ISO 13485, IEC 62304, ISO 14971, FDA regulations.

Responsibilities

• Serve as the Quality representative on NPD and sustenance projects.
• Define quality and compliance requirements for SaMD development and ensure they are communicated to stakeholders.
• Develop and implement software quality strategies, test plans, and validation approaches.
• Ensure compliance with SDLC processes and perform risk management activities including software hazard analysis and FMEA.
• Review quality deliverables for traceability, completeness, and testability across development lifecycle.
• Support audits, CAPAs, non-conformances, change controls, and DHF maintenance.
• Collaborate with R&D, Regulatory, Product Management, and Deployment teams; mentor junior engineers.

Skills

Risk Management

FMEA

ISO 14971

Quality Systems

Jira / Azure DevOps

Requirements Traceability

Root Cause Analysis

Cybersecurity

Regulatory Compliance

SDLC

Education

Bachelor's degree in CS/SE/EE/Biomedical

Master's degree preferred

Tools

Jira

Azure DevOps

Testrail

TrackWise

Salesforce

Slack

Job description

Senior Advance Quality Engineer

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 & 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% Experience Level Senior Level