Software Quality Assurance Engineer

Role : Software Quality Assurance Engineer

Location : Coimbatore, Tamil Nadu, India

Employment Type : Full-time | On-site

Role Description

We are seeking a Software Quality Assurance Engineer to join our Coimbatore delivery center, working on software development and migration programs for leading medical device customers globally. You will play a critical role in delivering high-quality, regulatory-compliant software solutions

Key Responsibilitie

Test strategy & planning

Design comprehensive test plans, test cases, and traceability matrices aligned with software requirements and regulatory standard.

Test execution

Execute manual and automated functional, regression, integration, system, and UAT testing for medical device software.

Test automation

Build and maintain automated test frameworks and scripts (Selenium, Pytest, Robot Framework) for repeatability and efficiency.

Regulatory compliance

Ensure quality activities comply with IEC 62304, ISO 13485, FDA 21 CFR Part 11, and applicable cybersecurity standards.

Validation & verification

Lead and support IQ/OQ/PQ validation activities, produce protocols and reports, and maintain complete audit-ready documentation.

Defect management

Log, track, and manage defects using Jira or Azure DevOps; analyze root causes and drive timely resolution with development teams.

Migration testing

Plan and execute data integrity, regression, and rollback testing for legacy-to-modern platform migration

Metrics & reporting

Track and report quality KPIs (defect density, test coverage, escape rate) to program managers and customers.

Required qualifications

• 8+ years of software QA experience, with 3+ years in medical devices or life sciences.
• Strong knowledge of IEC 62304 software lifecycle and ISO 13485, QMS
• Hands-on experience with manual and automated testing.
• Proficiency with defect tracking tools (Jira, Azure DevOps).
• Experience writing and executing validation protocols (IQ/OQ/PQ).
• Solid understanding of FDA 21 CFR Part 11 requirements.
• Excellent written communication skills for regulatory documentation.

Preferred qualifications

• ISTQB certification (Foundation or Advanced level.
• Experience with test automation frameworks (Selenium, Pytest, Robot Framework).
• Familiarity with HL7 FHIR, DICOM, or other health data standards.
• Exposure to cybersecurity testing (UL 2900, NIST guidelines).
• Knowledge of Agile / SAFe delivery models.
• Experience with API testing tools (Postman, REST-assured).
• Background in performance or load testing for regulated systems.

Why Join NovitiX

• Work with leading global Medical Device organizations.
• Lead high-impact digital transformation programs.
• Collaborative, growth-oriented environment