Diagonal Pharma develops a ground-breaking nucleic acid detection platform with high precision and accuracy for a fast, safe and easy pathogen diagnostics, including viruses. The company was founded during the COVID-19 pandemic in 2020 with the express goal to revolutionize diagnosis of viral diseases. The innovative technology that Diagonal Pharma develops is based on a combination of molecular biology, biochemistry, and electrochemical methods.
Diagonal Pharma strives to be an including company where we highly value diversity and equality. The operations are based in Lund, Sweden.
We are now looking for a Quality Manager to join our exciting journey and be a part of our fantastic team in Lund.
For more information about Diagonal Pharma please visit www.diagonalpharma.com.
In this position you will be responsible for the Quality Management System (QMS). You will also align the external and internal process and support audits. You will be the responsible person.
Furthermore you will:
- Establish and update SOPs, quality documents and templates
- Ensure compliance with developing partners
- Manage deviation reports
- Handle documentation of technical files
- Be responsible for planning and execution of supply audits
- Perform data analysis for reporting
- Be the contact person for external consultants
Education and Experience
- A relevant post-secondary education, for example a Bachelor or Master’s in Science or Engineering
- Preferably one-two years’ experience from working in a similar position
- A good knowledge of ISO 13485:2016 and IVDR/IVDD (MDR/MDD)
- Excellent communication skills, both written and verbal in English and Swedish
- Experience from establishing SOPs
- Experience from administration and documentation
- A good knowledge and experience from working in a Quality Management System
- A good knowledge in Excel and the Office suite
As a person you enjoy working in a team where you share responsibilities and tasks. You are well organized, structured with good planning skills. You are good at writing and reporting in a well-structured and logical way.
Also, we think that you as person is informal, stress resistant, positive, and flexible with an ability to handle many projects at the same time. Finally, you keep to schedules and follow procedures and policies and have a positive mindset.
As a Quality Manager you will report to our CEO and you will be based at our head office at Medicon Village in Lund.
For questions regarding this position please contact our Recruitment consultant Pernilla Agardh at +46 72 249 94 80. We will evaluate the applications on an ongoing basis and hire as soon as we have the right candidate.