Quality Assurance Manager
Description Quality Assurance Manager:
BioMed Elements B.V. is looking for an enthusiastic and ambitious Quality Assurance Manager to set up the quality department of the company. The QA Manager is responsible for all quality matters of both the organisation and the products that are developed and manufactured in house. The short term goal is to set up an ISO 13485 certified quality management system and support the project teams in writing technical files for market approval conforming to the Medical Device Directive. The long term goal of the position is to continuously improve the quality management system and ensure the organisation conforms to the high quality standards by acting as a sparring partner for the management.
- Set up and improve the ISO 13485 certified quality management system.
- Pro-actively support and supervise the project teams in writing technical files.
- Communicate with Notified Bodies and other relevant authorities.
- Write quality documents and ensure implementation in the organisation.
- Business partner of the management team.
What we expect of you:
- Minimum of 3 years relevant experience and education on MSc. level.
- Experience with setting up an ISO 13485 quality management system.
- Preferable experience in a medical production company.
- Experience with MDD 93/42/EG.
- Excellent communication skills in English, both verbally and in writing.
- Personality characteristics: analytical, accurate, self-starter, problem solver, strong focus
About the organisation:
BioMed Elements B.V. (www.biomed-elements.com) is an innovative spin-off of FutureChemistry Holding B.V., which uses a patented chemical production technology. This technology is used to develop and manufacture medical devices in various applications. The short term goal is to develop and market a number of medical devices. On the middle long term a number of products will be added to the development pipeline to ensure the growth of the company by developing innovative features to medical devices.
Taking into account the phase of the organisation, we are looking for someone who is ready for the future growth of the company. BioMed Elements consists of an enthusiastic team with a high level of ambition. You have to be smart, flexible and ambitious so the organisation can become a notable player in the field of biomaterials.
For more information or to apply for the position, please contact Tonny Voermans. If you are interested submit your CV and motivational letter accompanied by your working conditions to email@example.com.