Senior Advance Quality Engineer

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

Job summary

Stryker Corporation in India is seeking a Quality representative for NPD and sustenance engineering projects focused on SaMD and software products. You will define quality requirements and ensure stakeholders meet them, partnering with R&D, Regulatory Affairs, and Manufacturing.

You will develop and execute software quality strategies, manage risk analyses (FMEA, ISO 14971), ensure verification and validation, support audits, and maintain the Design History File.

Qualifications

• Bachelor's degree in CS/SE/EBE or related field; Master's preferred.
• 5–7 years in Software Quality Assurance or Software Engineering.
• Experience in regulated environments (Medical Devices, Healthcare Software).
• Familiar with ISO 13485, IEC 62304, ISO 14971 and change control processes.
• Cybersecurity concepts and regulatory considerations knowledge.

Responsibilities

• Define quality and compliance requirements for SaMD development.
• Develop SDLC processes for software development and testing.
• Lead risk management, including FMEA and software hazard analyses.
• Review and approve quality deliverables throughout the lifecycle.
• Support audits and manage CAPAs, non-conformances, deviations, and changes.
• Maintain Design History File and software quality documentation.
• Mentor junior quality engineers and collaborate cross-functionally.

Skills

Medical device development

ISO 14971 risk management

SDLC (IEC 62304)

Software quality assurance

Agile methodologies

Regulatory standards

Education

Bachelor's degree in Computer Science / Software Engineering / Electronics / Biomedical Engineering

Tools

Jira

Azure DevOps

TrackWise

Salesforce

Slack

Job description

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 & 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%

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.