Senior Advance Quality Engineer

Stryker Corporation; Gurugram District; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Stryker Corporation in Gurugram, India, seeks a Senior Advance Quality Engineer to act as the quality lead on NPD and sustenance projects for SaMD and software products. Hybrid work arrangement with 10% travel, you will develop QA processes, ensure SDLC compliance, and drive risk management across the development lifecycle.

You will review and approve quality deliverables, manage traceability, and support audits and CAPAs while mentoring junior engineers and coordinating with regulatory and R&D

Qualifications

• Experience in Medical Device Development and NPD
• Knowledge of ISO 13485, 21 CFR 820, ISO 9001
• Familiar with ISO 14971 risk management and safety analyses
• Experience with software safety standards IEC 62304 and cybersecurity
• Proficient in SDLC, V&V, verification activities and traceability
• Ability to lead audits and CAPA processes
• Strong communication and cross-functional collaboration

Responsibilities

• Represent quality on NPD and sustainment projects
• Define software quality requirements for SaMD and ensure SDLC compliance
• Develop QA processes for software development, testing and deployment
• Participate in reviews across requirements, design, code, V&V and risk management
• Maintain DHF and software quality documentation; ensure traceability and test coverage
• Support audits, CAPAs, non-conformances and change controls
• Mentor junior engineers and collaborate with cross-functional teams

Skills

SDLC

Risk Management

FMEA

RCA

Cybersecurity

Jira

Azure DevOps

Traceability

V&V

Test Management

Education

Bachelor's in CS/Software Eng/Electronics/Biomedical Eng

Master's degree preferred

Tools

Jira

Azure DevOps

TrackWise

Salesforce

Slack

Job description

## Senior Advance Quality EngineerApply: Gurugram, India: Full time: Posted Today: R574413Work 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 & 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 methodologiesTravel Percentage: 10%