We are currently looking for a Quality Engineer & Design Assurance to Coala Life in Uppsala – A Unique Opportunity to be a Part of Establishing the Future of Heart Monitoring.
Would you like to be a part of a growing team at one of Uppsala’s cutting edge life science companies? Then you do not want to miss this unique chance to work as a design assurance and quality engineer at Coala Life. The position is located at Coala Life’s office in Uppsala .
The Coala Heart Monitor is today used by healthcare professionals as well as private persons. Globally and nationally, the Coala is also used in research. To continue to deliver the high quality analysis, the team is now looking for a person with a background in the medical device industry. You should have a solid experience of working with medical devices and be open to working within a broad spectra of compliance related areas such as technical documentation, QMS management, risk management, and information security.
You will be part of a driven team that, quite literally, are following their hearts.
You will be responsible to support the establishment and maintenance of the Quality Management System and Information Security Management System, as well as working within all areas of these systems. The role also includes working with technical product documentation and risk management.
You will report to the Quality Manager and the detailed areas of responsibility will be outlined by the Quality Manager based on your background and expertise.
- University degree relevant for the position
- Solid experience of engineering work in ISO13485 and/or FDA regulated industry
- Experience of QMS management
- Experience from working with technical documentation for medical devices, hardware and/or software
- Handling of CAPAs, complaints and/or non-conformances
- Experience of work with risk management
- Excellent command of written and spoken English
We would also prefer that you have experience from working with information security management (ISO27001), design verification and validation, as well as data trending and performing internal and/or external audits.
As a person you are structured and have a systematical way of working. Good communication skills are key in interacting with the different departments of the company as well as external partners. You have a positive outlook on life and problem solving comes naturally to you, no matter how big or small a problem.
The position is initially a consultant role, where your employer is Randstad, whilst the long term intention is that you become part of the Coala Life family.
Deadline for application is 2020-01-26. Selection is continuous and the position may be filled before the last day of application – therefore, apply as soon as possible.
For information please contact Viktoria Ahlgren, firstname.lastname@example.org, 0724518798
about Coala Life AB.
Coala Life is a Swedish digital health venture focused on cardiac diagnostics and digital health. The company has developed a portfolio of innovative, unique and patented class-leading medical products and services for user-centered digital remote monitoring and screening of the heart based on advanced and smart algorithms. Coala’s solutions enable analysis, remote monitoring, more effective cardiac assessments and integrated care services, all in real time. Coala was named one of five global Cool Vendors within the Health and Wellness market by Gartner Group in 2018 and recognized as of the 100 Global Leaders in Digital Health by the Journal of mHealth.
For more information about Coala Life, please visit:
With more than 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry and offers staffing, consulting and recruitment solutions in all areas of expertise. We also offer interim management, executive search and outplacement services. We have a large network of clients and candidates, which means that we convey hundreds of jobs within different industries all over Sweden. Our ambition is to be the best employer in the market.
By combining our passion for people with the power of today’s technology, we help people and organizations to reach their true potential. We call it Human Forward.
As a consultant at Randstad you have a collective agreement which gives you the best possible market-adjusted benefits, terms and conditions. Randstad is a member of the Almega employers’ association and is a party to the staffing agreement with Unionen and Akademikerförbunden, which are both union organisations. You’ll get an annual wellness allowance of up to SEK 2,000 alongside discounted gym membership. We are also associated with an occupational health service. This means that you can get help with preventive and health-enhancing measures as well as with work-related health issues and rehabilitation. For a small fee, you get top-up insurance cover for you and your family.