SAXOCON A/S is hiring a quality assurance specialist to develop and maintain our Quality Management System (QMS). SAXOCON is in the process of implementing a QMS based on ISO 13485:2016. The Quality Assurance specialist is responsible for planning and managing the QMS in close collaboration with our Operation Manager and the rest of the SAXOCON team.

The candidate might be a Quality Assurance Specialist or Quality Assurance Assistant who wants to move to the next level and be responsibility for a QMS in a fast growing Consultancy Company serving the medical device industry. You will report to the Operation Manager.

Your main responsibilities cover: 

  • Responsible development and documentation of our ISO 13485:2016 Quality Management System, including supporting our upcoming audit associated with the QMS.
  • Working with operating team to establish SOP’s, standards, systems and procedures
  • Acting as a catalyst for change and improvement in performance and quality
  • Being an advocate for Best Practices and Quality throughout the company

Qualifications:

We expect you to have the following qualifications:

  • An BSc or MSc, in production with flair and interest for quality management
  • Knowledge from pharmaceutical, medical or biological industry is an advantage – but not mandatory.
  • At least 3 years of quality assurance experience
  • Proficiency and experience in the preparation of documents for QMS
  • Super-user of MS office and flair for other IT tools
  • Experience with ISO 13485/9001 Compliance audit, writing standard operating

In addition you are:

  • A dedicated team player with strong collaboration skills with internal and external stakeholders as we work cross-functionally and our team consists of toxicologists, computational toxicologists.
  • Pro-active, structured, well-organized and committed to meeting deadlines
  • Able to work on multiple tasks in parallel
  • Fluent in English, both written and orally
  • Able to see the bigger picture while keeping attention to detail
  • Passionate about quality management

About SAXOCON A/S

SAXOCON is a spin-off from DTU and is partly owned by DTU. The company was founded in 2013 and we are currently expanding heavily, both in number of employees and in our portfolio of customers.

SAXOCON A/S is a 2019 Gazelle Company – and was rated no. 22 out of 2.052 Gazelle Companies.

Although we are busy, we have a relaxed and informal atmosphere, where we collaborate to create high quality products to the benefit of our customers.

Any questions you are welcome to contact our CEO – Martin Friis-Mikkelsen on +45 40112027.