Quality Assurance Specialist (SaMD)
Tata Elxsi · Posted Sep 30
Design and technology services, product engineering, systems integration, and digital transformation solutions
Get a personal compatibility score
Add a resume for personal matches
About the role
Tata Elxsi is a design and technology services company, and this role sits in its medical device software quality function, supporting the development of Software as a Medical Device (SaMD) products. The work centers on design controls, software lifecycle verification and validation, ISO 14971 risk management, and audit readiness across the product lifecycle. The specialist acts as quality representative for assigned product teams, maintains DHF and risk management documentation, and supports QMS processes such as CAPA, complaints, and nonconformance management in line with FDA, EU MDR, and ISO 13485 requirements.
What you will do
- Provide quality oversight for SaMD product development, design controls, software lifecycle activities, verification/validation, release, and design transfer.
- Review and maintain traceability between user needs, requirements, risk controls, test cases, and results.
- Support Design History File (DHF) and technical documentation to ensure audit readiness.
- Facilitate ISO 14971 risk management activities, including hazard analysis, risk evaluation, control implementation, residual risk assessment, and cybersecurity reviews.
- Maintain Risk Management Files and ensure risk updates throughout the product lifecycle.
- Own or support key QMS processes including CAPA, complaint handling, nonconformance management, document control, and continuous improvement activities.
- Conduct investigations, root cause analysis, effectiveness checks, and compliance assessments within required timelines.
- Support internal audits, regulatory inspections, and external audits (FDA, Notified Body, MDSAP, ISO 13485).
- Perform gap assessments and integration activities for acquired products, QMS processes, and design documentation.
- Act as the quality representative for assigned product teams, provide compliance guidance, and escalate quality risks when required.
Skills used in this role
What the employer is looking for
- Bachelor's degree in a relevant discipline or equivalent experience.
- 3 to 8 years of experience in a regulated industry; medical device and SaMD experience preferred.
- Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 81001-5-1, FDA Quality System/Quality Management System requirements, 21 CFR Part 11, and 21 CFR Part 820.
- Working knowledge of software development lifecycles, Agile methodologies, and application of design controls within software development.
- Experience participating in regulatory, certification, or quality system audits is desirable.
- Excellent written and verbal communication skills with the ability to create clear, compliant, and defensible quality records.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities
Benefits and support
- Compensation and benefits are detailed in the job posting
About Tata Elxsi
Tata Elxsi is a global provider of design-led technology services, specializing in product engineering, systems integration, and digital transformation. Operating across sectors like transportation, healthcare, and media, the company combines design thinking with advanced technologies such as AI, cloud, and IoT to help enterprises build connected, intelligent products.
- Industry
- Design Services
- Company size
- 11500+ employees
- Founded
- 1989
- Location
- Bengaluru, India
- Funding stage
- Public Company
Funding
Public Company · $0 raised
Leadership
Manoj Raghavan
CEO & Managing Director
Nalin Rana
Chief Financial Officer
Recent coverage
Tata Elxsi Press Release
Tata Elxsi Invests in KAVIA AI to Scale AI-Driven Software Engineering for Products and Enterprises2026-09-10
Tata Elxsi Press Release
Tata Elxsi and Sarla Aviation Partner to Accelerate Development of Shunya, India's First Indigenous eVTOL Aircraft2026-09-01
Tata Elxsi Press Release
SCTIMST and Tata Elxsi Forge Strategic Partnership to Accelerate Healthcare Innovation and Medical Technology Development2026-07-27
Tata Elxsi Press Release
Tata Elxsi delivers steady growth at 2.8% QoQ and 14.5% YoY in Q1 FY272026-07-14