Head of QA/RA
At Trifork we're looking for a Head of QA/RA to join our team.
Full-time · Aarhus C, Denmark
Head of QA/RA
If you are experienced with quality assurance and regulatory affairs, love working in specialized teams, and you love working with mission-critical Medical Device software solutions within healthcare industry you might be the new colleague we are looking for:
In Trifork we focus on delivering quality and we are proud to do so. We have an ISO 13485 certificate to show for it. Our clients range from small startups to national authorities home and abroad and we handle their data and solutions - whether it concerns device data or highly confidential patient records. Trifork is primarily a consultancy house which means you will work on behalf of clients on a daily basis and we expect you are willing to challenge and guide clients in order to deliver the best solution to their needs.
As Head of QA/RA in Trifork you will work in agile and cross-functional teams with highly skilled colleagues through the entire development process.
Experience in quality management, clinical evaluation, post-market surveillance, and product documentation will be a significant advantage in this role.
You have a technical educational background or scientific educational background.
You are a team player who values integrity and honesty.
You love to collaborate closely with development teams to ensure compliance with regulatory guidelines.
You have experience with MDR and certificate management.
You have +5 years experience with ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001, ISO 23053 (we know the list could be longer, send us yours).
You love being in the center of company audits.
Continuously update and adjust regulatory procedures based on market feedback and changes in legal requirements.
Our daily work is characterised by an open and honest atmosphere, and we put emphasis on creating a challenging yet fun working environment. We work in agile and cross-functional teams with a focus on helping each other. We work in close collaboration with customers and make sure we understand their environment and issues.
We offer development and learning opportunities both within projects as well as in internal tech meetings, Trifork Hackerdays, annual team building trip and team events thoughout the year, conference attendance etc. In addition you'll get:
An open and informal environment
Opportunities for initiatives
All-you-can-eat lunch
Freshmade Italian coffee
Office overlooking the harbour and easy access to public bus and train transportation (e.g. Aarhus Letbane)
Macbook Pro or high-end Dell laptop (OS of choice) and smartphone (of own choice)
Do you want to join our team as our new Head of QA/RA? Then we'd love to hear about you!