We are expanding and need to strengthen our team with two experienced Quality Assurance and Regulatory Affairs professionals for immediate employment.What we offer
We offer you the opportunity to become an integral part of our exciting journey, within the field of medical temperature management, with the aim of improving the clinical outcome of patients who have suffered from sudden cardiac arrest, ischemic stroke, sepsis, difficult to treat fever and other related indications that may benefit from mild hypothermia treatment.
As a Director of Quality Assurance and Director of Regulatory Affairs in a small, but growing, company you will be an important contributor to the success of QuickCool in your respective fields, but also in other aspects of our open, flat organisation. Our patented system is designed to reduce and minimize potential brain injury after patients have suffered from lack of oxygen for a limited period of time, by inducing mild hypothermia treatment. Our patented solution comprises balloon catheters that are inserted into the nasal cavity and connected to a portable cooling device. Cold saline solution is circulated in a closed system to the nasal cavity that cools the brain and body of the patient.
Our initial markets include the EU, but we will enter all major markets as soon as practically possible after we have acquired our CE-mark. You will be part of the management team of QuickCool. We offer flexible working conditions including the option of being able to work from home - freedom with responsibility is our guiding principle!About the position
We are looking for a professional Director of Quality Assurance and Director of Regulatory Affairs with a minimum 3 years of professional experience from the Medical Device industry, particularly SO13485, MEDDEV, CFR and risk management, ISO14971 according to ISO 62304. Some of the main tasks in our QA/RA team include:
- Minimum 3 years of professional experience within ISO13485, MEDDEV and CFR
- Minimum 3 years of professional experience within risk management, ISO14971
- Minimum 3 years of professional experience from auditing, medical device design, development, manufacturing and post market surveillance.
- Work according to and ensure compliance to QuickCool ABs Quality Management System (QMS)
- Implement and maintain a functioning QMS
- Planning and performing internal audits and external audits on behalf of the company
- Complaint handling, including reporting incidents
- Company representative vis-à-vis notified body and relevant authorities
- Regulatory surveillance within the medical device field that is applicable to QuickCool
- Ensure compliance to relevant parts of MEDDEV and/or CFR
You have at least a Bachelor or similar high-level degree and have worked with MDD/MDR/ISO 14971 Risk Management and ISO13485. You are pragmatic in implementing and adhering to the applicable regulatory framework. We trust and hope that you are as passionate about saving and changing peoples lives for the better - just as we are.Additional:
- Good command of English and Swedish - both spoken and written.
- You must enjoy trying new approaches and being prepared to try new tasks.
- You must enjoy working in a small company. We are like a family.
- Your work may involve some overseas travelling.
Please apply through the form to the right, we advise you to apply as soon as possible as we review and interview continuously. All applications are treated confidentially. If you have any questions about the job, please contact CEO Fredrik Radencrantz, firstname.lastname@example.org, +46 (0)73 834 11 88
We are not able to accept applications via e-mail.About QuickcoolQuickCool is a Swedish medical technology company founded in 2003, whose business concept is saving lives by preventing brain damage caused by inadequate blood supply to the brain. The technique is a globally patented cooling system comprising an active device and disposable set.QuickCool is active in the fast-growing market, Targeted Temperature Management (TTM), for brain-protective cooling treatment of patients with e.g. sudden cardiac arrest. QuickCool’s solution protects the brain by cooling in the nasal cavity and thus taking advantage of the innate heat exchanger in the nose. QuickCool is listed on Spotlight Stock Market and conducts its business at Ideon Science Park in Lund. Read more about us at www.quickcool.se.