Join our dedicated team and become part of a company applying state-of-the-art technology to improve the lives of millions of diabetics worldwide
At RSP Systems A/S, we are developing a truly non-invasive glucose meter based on Raman spectroscopy and are striving to bring painless glucose monitoring to diabetics all over the world. To strengthen our development efforts, we are looking for a new colleague, who can handle the ever-changing international regulatory environment, an emerging MedTech company finds itself in.
RSP Systems is currently seeking a trained QA assistant/engineer for the overall documentation and registration related to launching a highly technical Medical Device on international markets.
The QA/RA Engineer is expected to work within the Quality Assurance and Regulatory Affairs department of RSP Systems. As a part of our QA/RA team, you will be assigned your own responsibilities and work in close collaboration with your colleagues. Your main tasks will include:
- Development and maintenance of the Quality Management System (RSP uses MasterControl) according to ISO:13485:2016
- Participation and support of software validation and verification
- Assistance ensuring risk management processes throughout usability engineering, development and post-production
- Planning, execution and follow-up on internal audits
- Diverse administrative tasks.
We offer an inspiring dynamic work environment with an opportunity to work with a wide array of tasks within Quality and Regulatory aspects. You will get insight into- and experience with the quality-regulatory processes before bringing an innovative device to market. RSP Systems value highly motivated and purpose-driven team members, providing you with the opportunity to develop professionally and influence your future line of work.
The successful candidate has, preferably, worked with Medical Device Standards such as ISO 13485 and Medical Device Directive (MDR/MDD) and is willing to maintain and develop his/her knowledge within these fields. As RSP Systems is ISO 13485 certified, qualifications within ISO 13485:2016 is an advantage.
We expect that you:
- Possess strong interpersonal and communication skills and is proficient with both written and spoken English.
- Work highly organized and detail-oriented, and can complete assignments with minimal supervision
- Are flexible and able to work with deadlines
Prior experience with MasterControl, ISO 60601 and Risk Management is preferred but not a requirement.
The position is full-time and initially limited to 12 months with the possibility of extension. Our offices are located in Odense, Denmark.
Contact and application:
For more information, you are welcome to contact QA/RA Director, Jens Johansen, at email@example.com.
Kindly send your application either by mail to Sivlandvænget 27C, 5260 Odense S, in person, or to our email address firstname.lastname@example.org (preferably through a secure mail account to ensure encryption of your data).
The deadline for applications is the 6th of March 2020. The desired start date is as soon as possible. Interviews will be held as relevant applications are received.
About RSP Systems A/S:
RSP Systems A/S is a Danish medical technology company focused on bringing innovative, non-invasive glucose monitors to people with diabetes. We are a team of world-class engineers and specialists, serious about science and committed to quality.
RSP’s technology is based on a direct optical detection principle, Raman spectroscopy, a mature technology to which RSP has developed and patented improvements enabling the measurement of concentrations of various substances in the interstitial fluid (tissue fluid surrounding the cells of the body) non-invasively through the skin. Proof-of-concept for glucose measurement on diabetics has been demonstrated through pilot trials in collaboration with Odense University Hospital in Denmark.
As a team, we are passionate about the work we do and excited about the positive impact it will have on diabetics around the world. With just over 30 employees, we maintain in many ways a relaxed family atmosphere, eating daily together and winding down every Friday afternoon, often to themed hangouts. You can expect a warm and flexible atmosphere, where your input matters.