Join Us in Catalyzing Brain Health Therapy with Real-World Data

At UNEEG Medical, we are on a clear mission: improve epilepsy care and ultimately enhance patients’ quality of life through objective, real-world EEG data. Our sub-scalp EEG solution enables remote monitoring of brain activity and is already making an impact across Europe and the US. We are entrepreneurial and ambitious, blending the agility of a small company with the high standards expected in medical device industry.

Your role and team:

We are looking for a Quality Assurance Specialist who will play a key role in maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and standards for medical devices.

Our product portfolio consists of implantable, wearable and communication devices, which are class III medical devices in EU. We are already commercially available in Europe, and we are advancing towards US market entry. As a Quality Assurance Specialist you will support activities across the product lifecycle, including design and manufacturing changes, supplier quality management and complaint investigations, and contribute to continuous improvement and regulatory excellence through collaboration and quality expertise.

You will be part of our Regulatory & Quality team that collaborates closely with colleagues across the organization and external consultants to achieve our common goals. In the team we are transparent about our challenges and step in to help others when needed. We continuously seek to improve our processes and personal knowledge.

Your main responsibilities will be:

• Ensure professional and proactive quality assurance support in project related to design and manufacturing changes for hardware and software devices

• Support the organization with resolving quality issues and implementing process improvements

• Support internal and external audits, including planning, preparation, execution, and follow-up of corrective actions

• Ensure quality supplier management including Quality Agreements, evaluation of suppliers and supplier audits (planning, preparation and execution)

• Release products for sale/clinical investigations including release of products by concession.

• Handle complaints, corrective and preventive actions (CAPA) and non-conformities (NC)

• Contribute to continuous improvement and maintenance of quality assurance processes

• Ensure operation and maintenance of Highstage (electronic documentation system)

You will thrive in this role if you have:

• A team-player mentality – Collaboration is fundamental in this role as you will be working closely with and proactively seeking guidance from colleagues across the organization

• A problem-solving mindset – Being pragmatic, resilient, and ready to take on new challenges as priorities shift

Your background:

• Minimum a bachelor’s degree in engineering or other natural science

• Ideally, you have at least 3 years’ experience in quality assurance in a regulated industry – preferable within medical device

• Experience working with ISO 13485, FDA 21 CFR Part 820 and other relevant standards and regulations

• Experience with design control of software and hardware devices

• Experience with supplier quality management within medical devices including performing supplier evaluation and audits.

It will be an advantage if you have additional experience with:

• Complaint investigations, CAPA’s and/or non-conformities

• Risk management, process validation and/or qualification of equipment

• Software as medical device (SaMD)

• Highstage

Who are you as a person:

• You have excellent planning skills and can work on several tasks simultaneously

• You are detail-oriented with strong analytical and problem-solving skills

• You are proactive, organized, and committed to continuous improvement

• You have a pragmatic mindset when solving tasks

• You can work independently and collaboratively in a team environment

• You are fluent in English, spoken and written

Applicants must be eligible to work in Denmark and possess a valid work and residence permit if applicable. At this time, we are unable to support work permit applications or sponsorships.

What we offer:

• A tight-knit team with a collaborative spirit and high professional standards

• A workplace with great energy, social activities, and a culture of togetherness

• A role based in our modern HQ in Allerød with good facilities and easy access

At UNEEG, your ideas matter, your work makes a difference, and your colleagues have your back.

Who to contact:

For more details about the job, please contact Senior Director, Regulatory & Quality, Camilla Wismar, at +45 4018 4937.

How to apply:

Apply through our Careers site.

All applications must be in English and are treated confidentially. We will screen and invite candidates for interviews on an ongoing basis.

About UNEEG Medical

UNEEG Medical pioneers ultra long-term subcutaneous EEG monitoring to help physicians optimize treatment for epilepsy patients. Our CE-marked UNEEG EpiSight solution provides objective insights into seizure burden, enabling more personalized care. We collaborate with leading institutions across Europe and the US to help patients regain control of their life. At UNEEG Medical, we are currently 40 dedicated people with diverse backgrounds. Our HQ is in Allerød with subsidiaries in UK, Germany, Austria and the US. Our core values Togetherness, Integrity, and Dedication guide our work as we catalyze brain health therapy with real-world data.