QA/RA Officer - medical software (part-time or full-time)

Job description

Promaton is changing dental healthcare by automating diagnostics and treatment workflows using AI, making healthcare more affordable and accessible for everyone.


Did you know dentists miss up to 30% of pathologies on an X-Ray? We are on a mission to eliminate errors in dentistry by improving diagnostic accuracy, and automating mundane work like creating 3D models by hand from an X-Ray, 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 affinity to startups and a passion for software and artificial intelligence. 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 ISO 62304). We have been ISO 13485 certified since 2018, and are planning to improve and automate (where possible) our QMS. You will be driving these improvements with the help of our technical team.

This role will be part-time or full-time, and can be fully remote (we are based in Amsterdam).

About us

Promaton is a four 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 guided implantology and orthodontics).


We are a group of 20+ 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.


Responsibilities

  • Maintenance of our company’s full Quality Management System (QMS) according to ISO 13485
  • Maintenance of our software development lifecycle processes according to ISO 62304
  • Maintenance of our product technical documentation (together with the product development team)
  • Fulfilling the annual Quality Management and Regulatory Assurance objectives
  • Management of all quality related communication internally and externally


Perks

  • 💰 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
  • ⛺️ 30 days of annual leave
  • 🛣 Job guarantee as we have secured long term funding



Job requirements

  • A passion for software engineering and/or artificial intelligence
  • One year or more working experience in the QA/RA domain
  • A strong doer and getting-things-done mentality
  • An independent work attitude
  • Willingness to learn (we are a very innovation-minded team)
  • Bsc or higher education
  • Experience with maintaining a Quality Management System (QMS) or similar
  • Excellent written and verbal communication skills in English
  • Experience with meeting requirements for ISO standards
  • Bonus: experience with and/or knowledge of ISO 13485, ISO 14971 and/or ISO 62304
  • Bonus: experience with and/or knowledge of MDR (or MDD), FDA
  • Bonus if remote: prior remote working experience


Sounds like you? Let's talk!