Engineer, Computer Software Assurance

📋 Description

• Lead the development and execution of comprehensive Computer System Validation (CSV) and Computer
• Oversee validation activities for GxP-regulated computerized systems, including enterprise resource
• Ensure computerized systems comply with applicable regulatory requirements, including FDA 21 CFR
• Develop, review, and maintain validation documentation, including User Requirements Specifications
• Apply risk-based validation methodologies to assess system functionality, identify compliance gaps
• Ensure data integrity, electronic records, electronic signatures, audit trails, and system security

🎯 Requirements

• At least 5 years of experience in Computer System Validation within a regulated medical device
• Advanced knowledge of FDA 21 CFR Part 11, 21 CFR Part 820, ISO 13485, ISO 14971, GAMP 5 guidelines
• Demonstrated experience leading the planning, execution, and documentation of validation activities
• Proven ability to develop and maintain comprehensive validation documentation, including URS
• Strong understanding of data integrity principles, audit trails, electronic records and signatures
• Excellent analytical, problem-solving, technical writing, and communication skills, with the

🎁 Benefits

• Competitive benefits package designed to support employee health, financial well-being, and
• Healthcare benefits and additional employee support programs, subject to location-specific policies.
• Paid time off to support personal needs and well-being.
• Potential remote-work flexibility, with the specific arrangement to be confirmed during recruitment.
• Professional development opportunities in computer software assurance, regulatory compliance, and
• Cross-functional collaboration with experienced professionals in quality, engineering, IT, and