Quality Engineer to Antaros Medical

Would you like to work as a Quality Engineer in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading.

At Antaros Medical, we are pioneering imaging methodologies, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET), to design and deliver clinical studies for decision making and differentiation in drug development.

We value competence and development as well as ideas and solutions. Relations and trust are keys to success, and it is equally important for us to have fun while doing a meaningful job. We currently have around 120 employees working at our offices in Sweden in Gothenburg, Uppsala and Malmö, as well as a newly established subsidiary in the US, and we are continuously growing and developing.

As a part of our growth journey and to deliver on our commitments, we are looking for a Quality Engineer to join our development team. The position will ideally be at our Uppsala office, but can possible be positioned at our office in Gothenburg as well.

As a Quality Engineer in our rapidly growing team, you will work with activities including quality assurance, software testing and DevOps. You will join a team that consists of Quality Engineers, Software Developers as well as Specialists in image processing and image analysis. Here, you will be responsible for ensuring that new software and systems are validated and that existing systems are maintained in a validated state. You will ensure that validation processes are followed, assist in testing and guide and support the organization in validation activities. In addition, your work role includes setup and support for build- and testing tools for software development.

Depending on your level of experience, your main responsibilities will be to:

- Ensure that all computerized systems are developed, implemented and validated according to defined processes, standards and regulations.

- Create plans for validation of new computerized systems and leading the work needed for implementation of the plans.
- Create and review documentation for validation of computerized systems, including validation plans, test protocols and validation reports.

- Support system owner with maintaining computerized systems in a validated state by performing periodic review, handling deviations, maintaining documentation, gathering user feedback etc.

- Advice software development team on validation of computerized systems.
- Handle issues, CAPAs and validation non-conformances.
- Continuous improvement of internal processes for development and validation.
- Lead and support risk management activities.
- Assist in customer audits.


Who are we looking for?

We are looking for a highly structured and communicative person that can maintain a high level of detail while still thriving in a dynamic and rapidly growing environment. You have a team-oriented approach and enjoy being part of a team that creates, implements and maintain high-quality systems. You also value having fun while doing a meaningful job.

Requirements:

- Bachelor´s degree in relevant field (Nature Sciences, Engineering, IT, Computer Science).
- Excellent knowledge of spoken and written English.


Meritorious:

- Experience from clinical trials from the pharmaceutical-, biotech- or medtech industry.
- Understanding of ICH-GCP, EU/Annex 11, GAMP and FDA/21 CFR part 11 and Data Integrity GxP requirements.


Are you interested?

Great to hear! Please submit your application via this link along with your CV included, no later than May 15, 2022

For more information about the position, please contact Carl Sjöberg, Manager Software Development, carl.sjoberg@antarosmedical.com +46 73 050 04 69

The recruitment is for permanent employment.

We only accept applications via our recruitment system, TeamTailor. The recruitment is handled by Antaros Medical.

About Antaros Medical

At Antaros Medical, we combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. We are specialized in cardiorenal & metabolic diseases and oncology. We have a global network of collaboration partners and customers, including both Big Pharma and Biotechs, and several European collaboration initiatives such as Innovative Medicines Initiative (IMI) and COST.

Antaros Medical has delivered small complex, mechanistic studies as well as multi-center clinical trials worldwide utilizing our innovative imaging methods. Our global headquarter and imaging Corelab are based in Sweden, and we have recently opened a subsidiary in the US. If you want to find out more about our company, go to our website: www.antarosmedical.com (https://antarosmedical.com/)