Software Quality Engineer (QA/RA)

Job Title: Software Quality Engineer (QA/RA) Location: Gurugram Haryana Department: Software R&D Company: SS Innovations About SS Innovations: SS Innovations is a cutting-edge medical technology company focused on developing advanced surgical systems and devices that improve the quality and accessibility of healthcare. As we continue to grow, we are looking for a proactive and detail-oriented Travel Desk Executive to join our team and manage all corporate travel needs efficiently. Job Description - Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market surveillance for software updates. Support validation and verification activities, including unit testing, integration testing, and system testing under regulatory frameworks. Deep understanding of IEC 62304, ISO 14971, ISO 13485, IEC 82304 guidelines, and Usability and FDA (Pre- and Post-market) Cybersecurity Guidelines. Prior experience with FDA 510(k) or PMA/De-Nova submissions and regulatory submissions. Maintaining a complete track record of all the software changes and documents. To Apply: Please send your resume and a brief cover letter to hr@ssinnovations.org Show more Show less