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Quality Officer for Medical Devices

Your Job

As quality officer you will carry a leading role in setting up, maintaining and reviewing the ISO 13485 Quality Management System (eQMS) for design, development and manufacturing of medical devices. You will oversee the processes throughout the expanding team of 8, make sure UV Smart is ready for Notified Body audits by the end of 2019 and maintain relations with all stakeholders.

As UV Smart aims to expand her portfolio over the next 3 years, an important part of the job is controlling the overall quality process and actively seeking ways to make it better. Not by working harder, but by working smarter.

  • You will coordinate and execute all the necessary actions for setting up, maintaining and reviewing UV Smart’s ISO 13485 Quality Management System and the accompanying CE certification path.

  • You provide the expanding team with the tools necessary to document key processes and request them in such a way you feel necessary to build a high quality QMS.

  • Together with the UV Smart directors, you set out the timeline, direction and required steps for the Technical Documentation, validation and verification during CE & FDA certification trajectories.

  • You will oversee the CE & FDA certification process for UV Smart’s product line.

  • You will work together with certification and regulation consultants to improve your own expertise and be ready for the new MDR requirements.

  • As expert you will train the UV Smart team with your findings and keep them updated on changes in the medical regulation field.

  • Your expertise will be required on design in- and outputs and risk analyses throughout product developments.

 

The Company

UV Smart is a well-funded start-up in the medical device industry. We develop and market high quality and high-tech UV-C disinfection solutions for hospitals and clinics in Europe, with the ambition to expand worldwide.

UV Smart has a flat organization structure composed of a young, ambitious and rapidly expanding team of 8 people, located in Delft, with a modern atmosphere and an informal culture. We have a passion for identifying problems and creating solutions for healthcare facilities and value a freedom and responsibility-based work culture.

Our technology enables medical professionals to easily and consistently disinfect their devices within 1 minute. We are developing two different disinfection devices, with different regulatory requirements, so prepare for some challenges.

The vacancy is for a full-time position (32-40 hours per week). We are flexible in work times but do prefer to be at the office when working. Fortunately, we have a very comfortable office in Delft nearby IKEA.

 

You Have

  • WO/HBO education level

  • Strong analytical skills and excellent command in English, both written and spoken.

  • Eye for detail, pragmatic and result oriented.

  • Active stance, without awaiting things to come your way.

  • Reliable energetic personality that delivers what is promised.

  • Prior experience with ISO 13485 standard QMS & Risk analysis

  • Prior experience with CE-certification.

  • (Preferred) Prior experience with Notified Body audits and communication.

  • (Preferred) Prior experience with FDA regulation.

  • Ability to work independently as well as part of a team. Open for feedback.

  • Ability and desire to assume a leadership role.

  • Ability to build long term relationships with clients and within the UV Smart network.

We Offer

  • An exciting, open work environment where new challenges are faced every day.

  • The opportunity to improve patient care and deliver high quality products.

  • Personal and professional growth and development opportunities.

  • A market conform salary.

Apply now