Do you want to be part of a small, global and expansive medtech-company in Uppsala with the vision to win the fight against the world’s most common causes of death? Are you a curious and committed person who is driven by the opportunity to work with the best in the industry and to take great responsibility? Then the job as a QA Engineer at Coala Life is for you.
About the job
As a QA Engineer, reporting to the Director Quality and Regulatory Affairs, you will have a broad scoop of responsibilities, all of them related to the regulatory compliance. Being part of a small company calls for an operational (and truly flexible) mindset. Deviation management, complaints, CAPA, change control, preparing for internal/external audits, writing and updating standard operating procedures, managing training records and risk management are parts of your daily work. You also handle registration and updates of our products. In addition, the company is certified according to ISO 27001 Information Security Management System, and the job includes work tasks to maintain this as well.
- University of Technology degree
- Experience in quality assurance and preferably regulatory affairs working with medical devices.
- Good understanding of applicable medical device regulations in EU and US.
- Good understanding of process standards, such as ISO 13485 and ISO 14971.
- Some knowledge of labelling requirement within the medical device industry.
- Experience of working with medical device software would be an advantage.
- Desirable, but not a requirement: Experience of working with Information Security Management System and GDPR.
Are you the one we are looking for?
We are always looking for rare talents. You have a sixth sense to make things happen, fast, and you love technology and design and of course you have a passion for doing good. You appreciate the high pace in a small and dynamic company, and you have experience of both quality and, preferably, regulatory requirements. Most certainly you are well organized, and you have a structured way of working. However, maybe the most important, you are a team player and you must have an ability and willingness to handle many different tasks and changes of priorities. You feel comfortable to align with colleagues to create practical and effective processes.
What can Coala offer you?
At Coala, you will have a great opportunity to develop in a global company with really high ambitions. Coala has received many awards and is ranked as one of the most exciting and promising health care growth companies in Sweden. Our new office in Uppsala, in walking distance from the train-station, will be your base but you can also work partially from home. This is a great opportunity to use and to strengthen your experience both in quality and regulatory.
This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to email@example.com
If you have questions regarding Coala Life or this open position, please contact Madeleine at +46 (0)73 026 22 63 or Tom Bergqvist at +46 (0)733 87 2722
By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.
Coala Life was founded in Sweden with a mission to develop patient-centric solutions powered by smart algorithms. The company is on a mission to digitally transform the field of cardiac diagnostics, to help win the battle against the world’s leading cause of death – heart disease.
The COALA Heart Monitor is used by thousands of patients and over 200 connected Healthcare providers to help detect early signs of heart disease and alleviate worries. Our unique innovations have received multiple prestigious awards and supported by over USD 20 million in funding.
We make it possible for everyone to monitor and analyze their heart. Anytime, anywhere.