Software Quality Assurance Engineer

United Pharma is focused on providing quality solutions in the medical device sector, and they are seeking a Software Quality Assurance Engineer to support software quality initiatives. The role involves performing software validation and verification, ensuring compliance with FDA and IEC standards, and collaborating with various teams to maintain quality throughout the software development lifecycle.

Responsibilities:

• Perform software validation and verification (V&V)
• Develop and execute test plans, test cases, protocols
• Maintain traceability (RTM) from requirements to testing
• Apply risk-based validation methodologies
• Support design control and SDLC documentation
• Track and manage defects, deviations, CAPAs
• Collaborate with QA, Regulatory, and Engineering teams
• Ensure compliance with FDA and IEC 62304 standards

Requirements:

• Strong experience in Software QA / Validation
• Experience in Medical Devices or SaMD (Mandatory)
• Hands-on with: IEC 62304
• Software Validation / CSV
• Traceability Matrix (RTM)
• Risk-based testing/validation
• Knowledge of SDLC, Agile/Scrum
• 3–7+ years in Software QA / Validation
• Experience in regulated medical device environment
• Exposure to FDA 21 CFR Part 820
• Experience with Design Controls / DHF
• Knowledge of ISO 13485 / ISO 14971
• Experience with test management tools