Software Quality Assurance Specialist
5 days ago
This is a unique opportunity to join a global medical device organization as their software validation site lead. As a software quality assurance specialist, you will play a critical role in ensuring compliance with FDA and ISO 13485 regulations.
Key Responsibilities:
- Lead software validation activities, including development and maintenance of validation plans, protocols, and documentation.
- Collaborate with cross-functional teams to ensure new software applications meet regulatory standards.
- Develop and maintain risk assessments, test scripts, and traceability matrices.
Requirements:
- Bachelor's degree in Engineering, Computer Science, or a related field.
- Five years of experience working in a regulated environment, specifically in medical devices.
- Strong understanding of software validation principles and regulatory requirements.
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