QA RA Specialist - Medical Software

February 7

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Promaton

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Promaton is a company at the forefront of integrating artificial intelligence into dentistry. By leveraging advanced AI technologies, Promaton aims to innovate the dental industry, enhancing diagnostics, treatment planning, and patient outcomes. The company is deeply involved in the tech and medical sectors, often exploring new technological innovations to improve its offerings. Promaton's focus on innovation is reflected in their participation in industry events like KubeCon and their continuous development of AI-driven dental solutions.

Artificial Intelligence • Image Analysis

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

📋 Description

• Promaton is on a mission to provide fast, more accessible and higher quality dental healthcare. • Seeking an experienced Quality Assurance & Regulatory Affairs (QA/RA) professional. • Work closely with the current QA/RA Manager to provide guidance on quality and regulatory compliance.

🎯 Requirements

• 3+ years of experience with ISO 13485. • Experience in managing typical QMS processes: document and record control, training, supplier management, Computer Software Validation (CSV), issue resolution (NCs and CAPAs), change management. • 2+ years of experience as QA/RA with software, including experience with ISO 14971 (risk management) and IEC 62304 (software product development). • Experience with organizing and documenting verification and validation activities. • Pragmatic approach balancing fast incremental improvements. • An independent and self-starter work attitude. • Willingness to learn, especially on AI regulations and standards. • Excellent written and verbal communication skills in English. • Based in a time zone between UTC-1 and UTC+3 (-2 to +2 hours Amsterdam time) • Ability to fly in for company events 4 times a year (1 week per quarter)

🏖️ Benefits

• Excellent employment terms • Freedom to work from anywhere (and any time you like). • Dedicated time for hackathons and research to explore new ideas of your own • Training budget for books, online courses, conferences, or anything else you need to grow • Work with cutting-edge technology at the forefront of rapidly evolving medical innovation • Loads of responsibility, autonomy and a chance to make a real impact • Awesome yearly company retreat and quarterly team events • Competitive annual leave package that varies by location • Top-notch gear • Promaton is funded for many years to come, meaning you can have the impact you only get at a startup but with the job security of an established company.