Senior QA Specialist

An innovative Israeli medical startup in the field of cardiology is looking for a senior quality specialist who will be the backbone of the company's QMS system - from documentation to audits - and will directly influence the quality and safety of products that change patients' lives. 📍 Location: Rehovot | Physical presence in the office | Non-hybrid 🎯 What will you do with us 📋 Maintenance and development of the QMS system in accordance with relevant regulations and standards 🔄 Leading Change Control processes - end-to-end approval of engineering and operational changes ⚙️ Performing and documenting validations for equipment, processes and systems in a production environment 🏭 Ongoing work with operations, production and engineering teams in the production rooms 🤝 Collaboration with multidisciplinary teams to promote quality goals and continuous improvement 🔍 Participation in internal and external audits with regulatory bodies

Job requirements

Mandatory Requirements 🎓 Bachelor's degree in Engineering or Science - Required 🏥 At least 5 years of experience in QA in the medical device industry only - experience in pharma alone is not sufficient 📐 Proven experience in Change Control and Validation processes - A significant advantage ⚙️ Experience working with operations and a manufacturing environment - An advantage 🌐 High-level English - written and spoken ⭐ An advantage ✔️ Familiarity with ISO 13485 and FDA / EU MDR regulations ✔️ Experience working in clean rooms or regulated manufacturing environments Why with us? ❤️ Cardiovascular technology with direct and measurable clinical impact 🚀 Growing startup environment - Expanding QA team, broad responsibility and exposure to all areas of quality 🌍 Working with international regulatory bodies in a company with active FDA approval

https://app.civi.co.il/promo/id=767918&hid=GHU3GL4MLL

nikolai812@tutamail.com