Quality Engineer to Antaros Medical

Would you like to work as a Quality Engineerin a company devoted to making a real difference in drug development through ground-breaking medical imaging?

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. We welcome applicants with different levels of experience and the position may be dynamically adjusted depending on seniority. We are primarily looking for someone to be stationed at our Uppsala office, but it could potentially be at our Gothenburg office for the right person.

As a Quality Engineer you will be an essential part of delivering validated systems and software to the operational organisation, and ensuring that systems remain in a validated state. You will ensure that validation processes are followed and teach and provide support to the organization in validation activities.At Antaros, we value competence and experience as well as novel ideas and innovative 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 130 employees working at our offices in Sweden in Gothenburg, Uppsala and Malmö, as well as a newly subsidiary in the US, and we are continuously growing and developing.

Depending on your level of experience, yourmain responsibilities willbe to:

• Support software development team as subject matter expert onvalidation process, including risk assessments
• Lead validation activities, including planning, documentation and risk-based implementation strategywhen new systems are implemented
• Conduct periodic review of validated systems
• Ensure thatvalidation documentation is accurately stored andorganized
• System administration
• Support development ofprocesses for validation and provide training on processes
• Participate in audits.

Who are we looking for?

We are looking for a highly structuredand communicativeperson that canmaintain a high level of detail while still thriving in a dynamic environment. You have a team-oriented approach and enjoy being part of a team that creates, implements and maintainhigh-qualitysystems.You also value having fun while doing a meaningful job.

Requirements:

• 1 year of experience in the pharmaceutical or medical device industry
• Bachelors degreein relevant field (Nature Sciences, Engineering, IT, Computer Science).
• Excellent knowledge of spoken and written English.
• Knowledge of computerized systemsvalidation

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 November 16th, 2024.Interviews will be continuously held during the advertisement period.

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 full-time employment.

We only accept applications via our recruitment system, TeamTailor. The recruitment is handled by Antaros Medical. We kindly decline any contact from recruitment- or staffing firms.

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. If you want to find out more about our company, go to our website: www.antarosmedical.com.

Our culture is our people, and our values makes us everything that we are. Please feel free to have a look upon our Culture Handbook to get to know us even more: Our culture - Antaros Medical.