Quality Engineer to Antaros Medical

at  Antaros Medical

Would you like to work as a Quality Engineer in 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.

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 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:

• 1 year of experience in the pharmaceutical or medical device industry
• Bachelor´s degree in relevant field (Nature Sciences, Engineering, IT, Computer Science).
• Excellent knowledge of spoken and written English.
• Knowledge of computerized systems validation

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.

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