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QA/RA Officer

Job Amsterdam, NL
Posted 2 Apr 2021

Degree level

Bachelor

Job function

Engineering

Required language

English (Fluent)

Work experience

2 to 5 years

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About us

Hello, we are easee! A high-tech healthcare startup offering the world's first CE-certified online eye exam that you can do at home with just a computer and a smartphone. We offer tele-health solutions for hospitals and we make it much easier to get new glasses or contacts online with the right prescription values. We save our customers the time to visit a hospital or optician. Our mission is to make clear vision accessible to everyone. Try it yourself at easee.online.

Our easee values are important to us: courage, impact, curiosity, quality and honesty. And at least of the same significance are our team values: open mindedness & respect. What do all these words mean?

  • Be open minded about everything, only that way you can learn something new.
  • Respect is one of the most important values when it comes to teamwork. It’s pretty simple: Treat others the same way you want to be treated.
  • If you have a good idea and are not 100% sure if you can do it, tend to just do it. It is better to ask for forgiveness than permission.
  • We make decisions based on the principle of “disagree and commit”. Getting everyone to fully agree on a plan is hard and takes too much time. Instead, we make decisions quickly and follow through.
  • We value efficiency and personal growth and have the resources available to make this happen.

About the job

Easee is a SaMD company that's EN ISO 13485:2016 certified. We expect you to lead our MDR transition, to maintain our QMS and work with R&D, Customer Support and Management to ensure compliant processes and products. We see Regulatory Compliance as a key differentiator and host a Meetup group for SaMD professionals. We offer you the opportunity to lead the way in regulatory compliance for low-risk agile software development and to show off!

What we expect

  • Develop and execute company’s regulatory strategy working closely with senior management team
  • Manage and supervise company quality management system
  • Perform periodic internal and external audits on company procedures and processes
  • Create, implement, and document processes together with internal cross-functional teams
  • Lead our medi­cal soft­ware cer­ti­fi­ca­tion pro­cess and oversee the continuous compliance for medical software in the EU (MDD, MDR)

About you

  • A university degree in a relevant area such as law, engineering or another scientific discipline
  • Experience with Quality Management Systems compliant with ISO 13485
  • At least two years’ experience within Regulatory Affairs and/or Quality Assurance for Medical Devices
  • Knowledge of and experience with submissions under MDD/MDR/FDA is a preference
  • Fluent English, second language is an asset
  • Analytical, independent, result driven

This is what we offer!

  • Be part of one of the most promising health-tech scale-up preparing to expand globally
  • Work in a highly motivated and talented international team with flat hierarchies; that is taking easee to the next level.
  • Freedom to execute your job in your way; we are results driven
  • Regular team easee events such as celebrating successes with Friday afternoon demos and drinks, Ping Pong table and WII
  • When you work in the office, a daily company lunch, free drinks and fresh fruits are provided by easee
  • 25 holidays per year on a full-time basis & additional public holidays
  • We invest in your personal development through training and education
  • We are headquartered in beautiful Amsterdam in an inspiring start-up hub where we share offices with inspiring start-ups like Disney+, Relay42 and many more
  • Learn in one year what normally takes five
  • A full-time job where you are able to (partially) work remotely


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Your eyes are your most important sensory organ. Especially in a world that is more visual than ever. It is our mission to make clear vision accessible to everyone. It starts with knowing how good your eyes are. A moment of clarity. Where and when it suits you.

Healthcare
Amsterdam
25 employees