HemCheck is developing a simple, yet sophisticated product addressing the issue of hemolyzed blood samples. The product concept consists of a single use point of care test and reader, ensuring the quality of blood samples. Saving lives, reducing costs and improving health care quality. Making every sample count. We are an innovative company addressing a new solution to a well-known problem. As HemCheck now is launching its first product on the market, it is of great importance for the company to have a complete quality management system that is in regulatory compliance. Therefore, we now look forward to strengthening the company with competence in the field of quality assurance and search for a candidate that wants to play an important role in the development, implementation and maintenance of HemCheck´s quality management system.
As a Quality Assurance Manager at HemCheck, your responsibilities will cover:
- Development and implementation of quality management system and product files (Processes and Procedures, such as risk analysis, validation, change control, CAPA, Post-Market Surveillance, writing and reviewing SOPs and other quality-related documents).
- Maintenance of existing quality management system and product files
- Monitoring and interpretation of legislations, standards and guidance
- Development and implementation of regulatory strategies
You have previous experience of work within the field of Quality Assurance, preferably from working within the medical device industry. You have good knowledge and understanding in IVDD/IVDR and/or MDD/MDR and other regulatory legislations that apply and can express yourself in both Swedish and English, both in writing and in speech. You are expected to be able to independently plan and run your daily work while being a team player and have a positive attitude towards work and colleagues. You also need a systematic approach combined with analytical ability. Great emphasis is placed on personal suitability.
Your professional skills preferably include:
- A university degree on bachelor or master level in Science or Technology
- Experience with regulations for IVD products.
- Experience from medical device industry.
- Experience in project management.
- Knowledge for standards for quality management system and risk management for medical devices, especially iSO 13485 and ISO 14971.
- Experience in writing SOPs and other quality-related documents.
Interviews will be held as soon as relevant candidates have been
Please send your application to email@example.com.
HemCheck is an innovative growing company that offers You to take part in an interesting journey from product development to product launch and market introduction of a unique patented solution. As being a team member of a smaller company You will be involved in all the regulatory steps and have full insight in the regulatory processes. hemCheck is listed at First North, Nasdaq and the company was founded 2010 and is based in Karlstad, Sweden. Additional company information is available at www.hemcheck.com.