Vill du vara med och kommersialisera en tjänst som både kan förbättra och effektivisera dagens hälso- och sjukvård?
Nu söker vi någon som kan stärka upp teamet med kompetens inom kvalitetssäkring. Vi söker dig som vill vara med och spela en viktig roll i arbetet med implementering, underhåll och vidareutvecklingen av Hemchecks kvalitetsstyrningssystem.
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Hemcheck Sweden AB Hemcheck was founded in 2010 with the vision of addressing the most common reason, hemolysis, for blood samples not being suitable for analysis. Hemolysis, the rupturing of red blood cells is a global problem that creates a lot of issues for the healthcare systems since the analytical results from analysis of hemolyzed blood samples are distorted and blood samples need to be redrawn in order to correctly analyze patient blood. Hemcheck is producing and selling a simple, yet sophisticated service addressing the issue of hemolyzed blood samples, at the point of care. The service consists of a product concept of single use point of care tests, a reader as well as training to medical staff. The concept enables healthcare staff to directly at the patient side detect hemolyzed blood samples and redraw the blood without leaving the patient. This will reduce waste, improve lead times, improve patient safety and healthcare quality while reducing overall costs. We are an innovative company addressing a new solution to a well-known problem. Hemcheck is listed at Nasdaq First North Growth Market and is based in Karlstad, Sweden. Additional company information is available at www.hemcheck.com.
Quality Assurance Manager As Hemcheck is launching its service in the market, it is of great importance for the company to have a complete quality management system in place that is in regulatory compliance. 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 implementation, maintenance and further development of Hemcheck´s quality management system. Main tasks As a Quality Assurance Manager at Hemcheck, your responsibilities will cover:
• Development and implementation of our 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
• Perform future GAP analysis towards already present standards
• Development and implementation of regulatory strategies
• Support the regulatory processes related to new market entries and new product launches
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 an 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 in project management
• Experience from medical device industry
• 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 identified. Please send your application to firstname.lastname@example.org.
Hemcheck is an innovative growing company that offers You to take part in an interesting journey from development to production 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.