Descripción
Quality Engineer at A3P Biomedical A3P Biomedical is a Swedish diagnostics company specializing in advanced prostate cancer diagnostics. Our main product, Stockholm3, is a blood test for early detection of aggressive prostate cancer — with the potential to radically improve diagnostics and reduce mortality in one of the world's most common cancers. We are currently active in Switzerland, Germany, the UK, the US, Austria, Poland, Turkey, Sweden, Norway, and Finland. To strengthen our Quality & Regulatory Affairs team, we are looking for a Quality Engineer to join us. You'll be part of a small, dedicated team and play an important role in maintaining and developing our Quality Management System. The role has a strong operational focus, with responsibility for supplier control, eQMS administration, the Master Validation Plan, and training. This is a role for someone who enjoys working hands-on with quality processes, takes ownership naturally, and wants their day-to-day work to make a real difference in patients' lives. Your responsibilities Maintain and develop supplier control processes, including supplier qualification, approval, monitoring, and documentation Coordinate and follow up supplier evaluations, quality agreements, and supplier-related quality activities Act as administrator and key user for the electronic Quality Management System (eQMS), including user administration, workflows, document control, and system support Own and maintain the Master Validation Plan, ensuring it is current, aligned with applicable requirements, and appropriately followed up Coordinate and administer QMS-related training and maintain training records Support deviations, CAPAs, change control, and other quality processes as required Support internal and external audits and inspections Contribute to the maintenance and continuous improvement of the Quality Management System in accordance with applicable requirements Collaborate closely with Operations, Regulatory Affairs, R&D, and