As quality officer, you will carry a leading role in further developing, 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 12, make sure UV Smart is ready for Notified Body audits throughout the year and support in certification of medical devices.
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 further developing, maintaining and reviewing UV Smart’s ISO 13485 Quality Management System and the accompanying CE certification paths.
- 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 hone your skill in the new MDR requirements.
- You will keep in close contact with our suppliers and distributors, visit them for audits and improve their performance whenever you see room for improvement.
- 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.
UV Smart is a well-funded scale-up in the medical device industry. We develop and market high-quality and high-tech UV-C disinfection solutions for hospitals and clinics in over 18 countries all over the world.
UV Smart has a flat organizational structure composed of a young, ambitious and rapidly expanding team of 12 people, located in Rijswijk, on the edge of Delft with a modern atmosphere and an informal culture. We have a passion for identifying problems and creating solutions for healthcare facilities and value freedom and responsibility-based work culture.
Our technology enables medical professionals to easily and consistently disinfect their devices within 1 minute. We are already selling two, and developing more 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, brand-new office.
- 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 (ISO 14971)
- 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.
Nice to have
- Fundamental understanding of underlying physics, ability to root cause from first principles
- Affection with technology and ability to identify or derive how things work
- 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.
- A nice lunch every day.
If you are interested in the following position you can send an email to email@example.com with your CV and motivation letter.