Overview
On Site
Full Time
Skills
Computer Science
Information Technology
Electronic Engineering
Verification And Validation
Medical Devices
Pharmaceutics
Health Care
Software Development
Risk Management
Quality Assurance
ISO 13485
GAMP
Software Development Methodology
Computerized System Validation
SOP
Training
Requirements Elicitation
Risk Assessment
Test Execution
Cross-functional Team
Documentation
Job Details
Roles & Responsibilities:
- Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field.
- Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries.
- Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles.
- Experience in handling SW development and verification tools.
- Good exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation.
- Experience with computerized system validation (CSV) approaches for non-product applications.
- Proficiency in authoring validation documents as per SOP or work instruction.
- Responsible for SW Validation planning, requirement gathering, Risk assessment, protocol development and test execution.
- Work with cross functional team and SME to understand the intended use and prepare the above documentation.
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