Senior Advance Quality Engineer

Stryker Group; Gurugram District; Hybrid; INR 1,500,000 - 1,900,000; Full time

Job summary

Stryker Group is hiring a Software Quality Assurance professional to lead quality activities in medical device software development for SaMD and non-med SW. You will define compliance requirements, oversee SDLC processes, perform risk management including FMEA, and ensure traceability and robust QA across the development lifecycle.

You will collaborate with R&D, Regulatory Affairs and Manufacturing, drive audits, CAPAs and change controls, and mentor junior quality engineers in a regulated

Qualifications

• Experience in Medical Device Development processes and NPD
• Knowledge of ISO 14971 and risk management techniques
• Familiarity with ISO 13485, 21 CFR 820, ISO 9001 and change control processes
• Experience in SDLC, V&V, defect management and requirements traceability
• Experience in audits and CAPA management

Responsibilities

• Serve as quality representative on NPD and sustenance projects
• Define quality and compliance requirements for SaMD development
• Develop SDLC process & procedures for SaMD or non medical SW
• Participate in reviews and drive risk management including FMEA
• Review and approve quality deliverables and traceability
• Develop and execute software quality strategies, test plans and validation
• Ensure verification/validation activities are performed and documented
• Ensure compliance with ISO 13485, FDA, IEC 62304 and cybersecurity requirements
• Support audits and address SW bugs, CAPAs, non-conformances and change controls
• Validate SW tools used in development, testing and deployment
• Ensure deployment compliance per customer requirements with R&D and deployment teams
• Maintain Design History File (DHF) and software quality documentation
• Collaborate with cross-functional teams and mentor junior quality engineers

Skills

Medical device development

ISO 14971

SDLC

V&V

Risk analysis

RCA

Cybersecurity

Product security

Quality management systems

Change control

Jira/Azure DevOps

Traceability

Audits

DHF

Education

Bachelors in CS/SE/EE/Biomed

Tools

Jira

Azure DevOps

Testrail

TrackWise

Salesforce

Slack

Job description

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 methodologies