CSV engineer

Company Description

Eurofins Li-Med specializes in regulatory activities and quality assurance exclusively for the medical device industry, with both domestic and international customers. Their experts produce comprehensive and submission-ready information to ensure compliance with regulations and approval for marketing and clinical trials. They stay in constant contact with authorities to remain up-to-date with evolving global regulatory requirements and support clients' endeavors by liaising with several prominent laboratories.

Role Description

Eurofins Li-Med is seeking a full-time CSV Engineer to join their team in Petah Tikva. The CSV Engineer will be responsible for developing and maintaining computer system validation (CSV) and data integrity procedures and records for medical devices. This is an on-site role in Petah Tikva with traveling abroad at least twice a month.

Qualifications

• Bachelor's degree in computer science, engineering, or a related field
• 3+ years of experience in CSV and data integrity, preferably in the medical device industry
• Familiarity with regulatory requirements of the FDA, EU, and other international agencies
• Experience with software validation, including development of software validation plans, user requirements, and test scripts
• Proficiency in programming languages such as Python and SQL
• Excellent communication and problem-solving skills, with the ability to work in a team-oriented environment
• Knowledge of quality assurance principles, including ISO 13485