Senior Quality Engineer - Operations

Job not on LinkedIn

May 19

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Logo of Neko Health

Neko Health

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

• Neko Health is a Swedish health-tech company co-founded in 2018. • Vision: Create a healthcare system to help people stay healthy through preventive measures. • New medical scanning technology for broad, non-invasive health data collection. • Remote-first company based in Stockholm with over 200 employees. • As a Senior Quality Operations Engineer, ensure effective QMS operations and compliance. • Oversee document and change control, feedback management, NC & CAPA, audits, training. • Ensure compliance with ISO 13485, EU MDR, and FDA regulations.

🎯 Requirements

• 5+ years of experience in Quality Operations or QMS management within the medical device industry. • Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and EU MDR. • Experience managing Document Control, Change Control, Complaints, NC & CAPA, and Audits. • Familiarity with Training Management systems and eQMS optimization. • Hands-on experience with electronic QMS (eQMS) workflows, with a mindset for process optimization. • Strong problem-solving, organizational, and communication skills. • Experience with AI/ML-driven quality systems or automated processes (Nice to Have). • Knowledge of post-market surveillance and supplier quality management (Nice to Have).

🏖️ Benefits

• Flexible workplace focusing on work/life balance. • Opportunity to shape the future of quality operations.

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