Job Summary

The Staff Software Quality Engineer serves as a senior quality partner to software product development teams, providing technical leadership and oversight to ensure software products are developed in compliance with company quality requirements, applicable regulations, and industry standards.

The role influences quality strategy and practices across complex product programs, mentors engineers, and partners with cross-functional teams to drive risk-based decision making, continuous improvement, and quality excellence in emerging technology areas, while remaining an individual contributor.

Responsibilities

- Provide software quality leadership across multiple product development programs throughout the Software Development Life Cycle (SDLC) and Product Development Process (PDP).
- Provide quality oversight and guidance for software development, verification, validation, cybersecurity, risk management, and product release activities.
- Review and approve software lifecycle deliverables, including requirements, design documentation, traceability records, risk management documentation, verification and validation documentation, cybersecurity documentation, and software change records.
- Lead resolution of complex software quality, compliance, and risk management challenges using a risk-based approach.
- Influence key product development decisions by applying software quality engineering principles, regulatory expectations, and practical understanding of product risk.
- Facilitate quality alignment across Software Development, Product Security, Regulatory Affairs, Product Management, and Program Management functions.
- Drive consistency and improvements in software quality processes, tools, templates, and practices across product teams.
- Lead or support software risk management activities throughout the product lifecycle.
- Support complaint investigations, CAPA activities,



audit observations, software nonconformances, and corrective action initiatives.
- Provide quality guidance for cloud-enabled, cybersecurity-related, AI-enabled, and data-driven software solutions, as applicable.
- Assess emerging technologies, development methodologies, and industry trends to identify quality and compliance improvement opportunities.
- Develop and promote best practices, guidance materials, and reusable quality frameworks that improve organizational effectiveness.
- Mentor and coach Software Quality Engineers and cross-functional stakeholders on software quality processes, regulatory expectations, and risk-based decision making.
- Act as a trusted advisor within the Software Quality organization, helping shape future quality capabilities, operating practices, and organizational best practices.
- Support internal and external audits and act as a subject matter expert for software quality-related topics.
- Identify organizational risks, quality concerns, and process improvement opportunities, escalating as appropriate.
- Contribute to strategic initiatives that strengthen software quality capabilities across the organization.
- Support other areas of the Quality System and perform additional tasks as defined by management.

All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Preferred Education

- Bachelor s degree in Computer Science,



Software Engineering, Bioinformatics, Biomedical or related discipline

Job Requirements
- 8+ years of experience in software quality engineering, software development, systems engineering, or a related discipline within a regulated industry.
- Working knowledge of applicable regulations and standards, including IEC 62304, ISO 13485, QMSR, FDA regulations, and software risk management practices.
- Robust understanding of software verification, validation, risk management, cybersecurity, and quality system requirements.
- Experience supporting regulated software products, including Software as a Medical Device (SaMD), cloud-based software solutions, or complex software-enabled systems.
- Demonstrated ability to influence technical and business decisions without direct authority.
- Experience leading complex cross-functional initiatives involving multiple stakeholders.
- Experience mentoring engineers or cross-functional partners on software quality practices and regulatory expectations.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent verbal and written communication skills with the ability to communicate effectively across technical and non-technical audiences.
- Experience supporting internal and external regulatory inspections and audits preferred.
- Quality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.) preferred.
- Occasional travel may be required.
- Willingness to work in shifts to support the US region (No night shift required).

This role is not eligible for visa sponsorship.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

📌 Staff Software Quality Engineer - Product Development (Bengaluru)
🏢 ILLUMINZ
📍 Bengaluru