A3P Biomedical AB is a commercial-stage company with a mission to improve the lives of men by radically improving precision in prostate cancer diagnostics and treatment. The lead product, Stockholm3, is a commercially validated blood test for early detection of prostate cancer.
A3P is a newly formed company that have developed the method, the algorithms, and the tools to improve the screening for prostate cancer used in Stockholm3. The companies cover the capabilities of wet-lab, algorithm development and logistics. A3P are now in the process of a private placement and in preparation for a planned IPO and international expansion.
Vision & mission
A3P vision is to significantly reduce prostate cancer mortality and healthcare cost, and improve quality of life, by earlier and more accurate risk assessment and improved treatment selection. The vision will be achieved through replacing PSA with Stockholm3 for early detection of prostate cancer.
A3P’s mission is to improve the lives of men by radically improving precision in prostate cancer diagnostics and treatment.
For more information, visit the company´s web sites at http://www.a3pbiomedical.com/sv/
Job Title: QA Manager
Reports to: Director Quality Assurance and Regulatory Affairs
A3P Biomedical AB is a commercial-stage innovative company with a mission to improve the lives of men by radically improving precision in prostate cancer diagnostics and treatment.
A3P Biomedical is looking for a QA Manager with a solid experience from leading roles within Quality Assurance and with Medical Device industry experience. The QA Manager will work with a wide range of QA activities to ensure compliance to Quality Management Standard ISO 13485 and applicable regulatory requirements (IVDD, IVDR and IEC62304).
We are looking for a highly skilled and motivated person with at least 5 years´ quality management experience within the medical device industry. The person needs to be a strong communicator, having the ability to work across different teams with different people, and pragmatic with a “can-do attitude”. It is also important to be able to take decisions and provide others with a clear direction. Good time management and meeting deadlines to drive performance is also important in this position.
Qualifications and experiences
• MSc degree within science or engineering or experience from a similar position
• Minimum 5 years in leading roles within Quality Assurance and Regulatory Compliance
• Demonstrable knowledge to quality management systems ISO 13485 and IVDD/IVDR
• Fluent in English and Swedish, oral and written
• Demonstrable knowledge to quality management system IEC62304 is a plus
• Knowledge in FDA 21CFR part 820 and part 11, and ISO 14971 is advantageous
• Medical Device industry experience, preferably in manufacturing and development of software IVD devices
• Strong communication and cooperation skills.
• Excellent coaching and people development skills.
• Pragmatic and a can-do attitude.
• Ability to switch between strategic and operational level.
• Structured, goal orientation and decisive.
• Emotional maturity and ability to remain calm while under pressure.
• Commitment to making a difference.
Opportunities with the role
• To contribute to A3P Biomedical very important mission; to improve the lives of men by radically improving precision in prostate cancer diagnostics and treatment
• A3P Biomedical solutions will significantly reduce prostate cancer mortality and healthcare cost, by earlier and more accurate risk assessment and improved treatment selection -A possibility to really make a different!
• Work with a ”State-of-the-art” product
• The possibility to work for a very exciting Swedish Life Science company with a high growth rate and a huge potential to grow further
• The possibility to work with very high quality, innovative and unique products that the society, healthcare and patients are asking for
• Work together with an experienced and very committed team, in a creative and very prestigeless and friendly environment
• Be part of a successful expansive and dynamic company focusing on research, innovation and results
• This is a key position, with the great opportunity to work with a broad spectrum of responsibilities, and to build, lead and develop the quality management system to secure success in the future
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details: email@example.com Tel: 070-386 89 69