UNEEG medical A/S

QA Specialist, QMS compliance for medical devices

UNEEG medical A/S Allerød


Do you have a passion for quality management? Then we offer you a challenging and exciting position!

As our new QA Specialist, your main responsibility will be to maintain and support optimization of the Quality Management System (QMS), including assisting other departments.

Our first product solution for monitoring and analysing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market. We are currently implementing the new European Medical Device Regulation (EU MDR) and in the coming year the plan is to implement the US Quality System Regulation (QSR), where you will play a key role in communicating requirements, ensuring requirements are incorporated in the QMS in a simple and effective way and organizing FDA Mock inspections.

To become successful, you must have a talent for creating good relations and facilitate improvement. You are an excellent team player but are confident in working on your own.

The department

You will be joining 7 highly dedicated and skilled colleagues in the QA/RA department. You will become part of an ambitious team with an informal relation, good humour and where we take care of each other. We are open and honest and appreciate a colleague who takes responsibility and have a positive approach to new challenges.

The QA/RA department have close cooperation with different stakeholders. As UNEEG medical is a small company the QA/RA department cover a broad range of tasks such as participating in development projects, maintaining and implementing new requirements in the quality management system, supporting manufacturing activities and market expansions.

Your key responsibilities:

  • Drive projects in QA/RA function including certification projects
  • Plan and perform internal audits
  • Organize external audits/inspections
  • Maintain and support optimization of the Quality Management System (QMS)
  • Coordinate and assist in the management review process

Your qualifications:

  • Bachelor’s degree, preferably in natural science
  • Minimum 2 years of experience within quality management of medical devices
  • Experience with QMS requirements from ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and MDSAP. Further, certification experience with ISO 27001 is an advantage
  • Certified Lead Auditor (ISO 13485)
  • Experience with internal and external audits
  • To succeed in the job, you are a pragmatic person with an open and communicative approach that is inspired to find new and smart ways to fulfil quality requirements
  • Given the international environment of UNEEG medical, English is our corporate language. You will use English in your daily work, which requires that you speak and write English at a high level.

Contact and application

Please send your application and CV in English. We will screen and invite candidates for interviews on a continuous basis, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

For further information about the position, please contact Head of QA/RA Camilla Wismar at +45 4018 4937 or cawi@uneeg.com.

About UNEEG medical A/S
UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life. Our unique subcutaneous EEG solution for remote monitoring of brain activity was CE marked in 2019 and our continued international growth and technology roadmap ambitions will require several new functions and competencies in the years to come.

UNEEG medical A/S was founded in 2005. We currently employ approximately 100 people in Europe – the majority of these are situated in our new headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience. Read more about us at www.uneeg.com