Senior Advance Quality Engineer

Stryker · Gurugram, India · full time · On site · 13 days ago

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Posted October 01, 2026 · Read from Stryker
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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

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%

Employer
Stryker
Location
Gurugram, India · On site
Contract
full time