CSV Engineer

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October 14

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Neko Health

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Healthcare Insurance • Wellness

Neko Health is a healthcare company offering advanced body scans and health check services in the United Kingdom and Sweden. They focus on providing comprehensive health evaluations using cutting-edge technology, allowing clients to receive instant results and detailed consultations with doctors. Their services include monitoring body measurements, blood vessels, heart rhythm, diabetes factors, and skin mapping. Neko Health emphasizes preventive healthcare and annual check-ups to help clients track changes and improve their health over time. The company aims to revolutionize healthcare by making thorough health checks accessible and emphasizing prevention over treatment.

11 - 50 employees

Founded 2018

⚕️ Healthcare Insurance

🧘 Wellness

💰 Series A on 2023-07

📋 Description

• Execute validation activities for software tools and computer systems used across engineering, manufacturing, operations, and quality. • Ensure validation activities are planned, executed, and documented in compliance with medical device regulations. • Champion a "quality beyond compliance" mindset that transforms validation activities into genuine business value. • Contribute to the company's success by ensuring systems are compliant, optimized for performance and efficiency.

🎯 Requirements

• 5+ years of experience in computer system validation, software validation, or similar roles within the medical device, regulated, or life sciences industries. • BSc or MSc in Computer Science, Engineering, Systems, or related technical discipline. • Experience validating both commercially-purchased systems and internally-developed software (including scripts and automation). • Working knowledge of regulatory requirements for system validation, including EU MDR (2017/745 Annex XI) and US FDA (21 CFR Part 820 and Part 11). • Practical experience with CSV principles, risk-based validation approaches, and frameworks such as GxP, GAMP, and ISO/TR 80002-2. • Experience working in agile development environments and applying iterative validation approaches that balance compliance with development velocity. • Skilled at writing and executing validation protocols, test cases, and reports. • Experience maintaining audit-ready documentation and supporting audit requests. • Strong analytical and problem-solving skills with attention to detail. • Excellent written and verbal communication skills in English.

🏖️ Benefits

• Flexible workplace focusing on work/life balance