Senior Advance Quality Engineer

Stryker · Gurugram, India

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Role summary

Stryker seeks a Senior Advance Quality Engineer to lead quality and compliance for software medical devices and non-medical software projects in a hybrid role based in Gurugram. The position involves defining quality requirements, conducting reviews across development lifecycles, ensuring regulatory compliance, and mentoring junior engineers.

What they're looking for

5-7 years experience in software quality assurance, software engineering, or quality engineering
4+ years in medical device development, new product development, or regulated environments
Proficiency with ISO 13485, FDA regulations, IEC 62304, and risk management frameworks including ISO 14971
Technical expertise in SDLC, V&V, requirements traceability, FMEA, and defect management tools
Bachelor's degree in Computer Science, Software Engineering, Electronics, Biomedical Engineering, or related field
Working knowledge of quality management systems and change control processes
Experience with tools such as Jira, Azure DevOps, Testrail, TrackWise, or Salesforce

What you'll be doing

Serve as quality representative on new product development and sustenance engineering projects
Define quality and compliance requirements for software medical devices and communicate to stakeholders
Develop processes and procedures for software development, testing, and deployment following SDLC standards
Conduct and drive reviews across requirements, design, verification, validation phases and risk management activities
Ensure regulatory compliance, support audits, manage software defects, and maintain Design History Files

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