QA/RA Officer - medical software (32-40h)

Promaton is changing the dental healthcare landscape by automating treatment planning workflows using AI, making healthcare more affordable and accessible for everyone. We are on a mission to eliminate errors in dentistry by improving diagnostic accuracy, and automating treatment planning workflows, see our company page to learn more about what we do.

We are a (software) medical device supplier, and are looking for a quality officer with a passion for software and artificial intelligence, an affinity to working in a flexible and small (startup) environment. You will be responsible for maintaining our ISO 13485 certified QMS and helping to maintain our product technical files (together with the product development team, which is developing according to IEC 62304). We have been ISO 13485 certified since 2018, and are planning to improve and automate our QMS wherever it’s possible. You will be driving these improvements with the help of our technical team.

This role will be remote, although you are welcome to work in our office in Amsterdam if that suits you.

Promaton is a six year old startup based in Amsterdam. Co-founded by two friends - a dentist and an AI specialist - we are building a number of algorithms that automate dental treatment workflows (such as for guided implantology and restorative treatment planning).

We are a group of 25+ strongly connected people with a passion for technological innovation in healthcare, and we maintain a culture based around honesty, transparency and a passion to build technology that improves healthcare.

• Maintenance of our company’s full Quality Management System (QMS) according to ISO 13485

• Fulfilling the annual Quality Management and Regulatory Assurance objectives

• Management of all quality related communication internally and externally

• 💰 Excellent employment terms

• 🏡 Freedom to work from anywhere you like (and any time you like). We only have a few touch points

• 💪 Loads of responsibility and autonomy, almost no bureaucracy and a chance to make a real impact

• 🏖 Awesome yearly company retreat, and quarterly team events

• ⛺️ 32 days of annual leave

• 🛣 Job guarantee as we have secured long term funding

• 3+ years of experience in the medical devices QA/RA domain (ISO 13485, IEC62304)

• Experience with QARA work in software products (bonus: artificial intelligence)

• Pragmatic approach balancing fast incremental improvements in procedures vs making larger changes

• An independent and self-starter work attitude

• Willingness to learn (we are a very innovation-minded team)

• Excellent written and verbal communication skills in English

Sounds like you? Let's talk!