Quality Engineer hos A3P Biomedical i Uppsala
Upprätthåller processer för leverantörskontroll, administrerar eQMS, hanterar Master Validation Plan samt koordinerar utbildningar. Kräver högskoleexamen inom relevant område och erfarenhet av kvalitetssäkring inom reglerad bransch.
Titel, arbetsplatsens namn och sammanfattning skrivna av AI utifrån annonsen.
Bra att veta
Lön
Inom yrkesgruppen Övriga ingenjörer och tekniker har de som jobbar i privat sektor i Östra Mellansverige i snitt 48 500 kr i månaden, varav 46 700 kr i grundlön. I hela landet, i privat sektor, tjänar hälften mellan 38 700 kr och 53 700 kr, och de som är 18–24 år har i snitt 33 500 kr. Det är statistik för yrket, inte vad den här arbetsgivaren betalar.
Källa: SCB, lönestrukturstatistik 2025
Anställningen
Anställningen har inget slutdatum. Den kan börja med en provanställning på högst sex månader. Vill arbetsgivaren avsluta den under provtiden ska du få besked minst två veckor i förväg; annars blir den en vanlig tillsvidareanställning när provtiden är slut. Därefter krävs sakliga skäl för att säga upp dig, och uppsägningstiden är minst en månad, längre ju längre du har varit anställd.
Ett kollektivavtal kan ge andra regler än lagen.
Texten är skriven med AI och kan innehålla fel. Kontrollera med arbetsgivaren.
Källa: Lagen om anställningsskydd (LAS)
Arbetsgivaren
A3P Biomedical har annonserat 2 jobb det senaste året: 2 tillsvidareanställningar. Det är deras första annons inom yrkesgruppen Övriga ingenjörer och tekniker på två år.
Källa: vår sammanställning av Arbetsförmedlingens annonser
Quality Engineer at A3P Biomedical
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 other functions to ensure effective and compliant quality processes
Working hours
Full-time
Required qualifications
- BSc or MSc (or equivalent) in Engineering, Life Sciences, Biomedical Engineering, Biotechnology, or another relevant discipline
Experience working with Quality Assurance or Quality Engineering in the medical device, in vitro diagnostics, pharmaceutical, biotechnology, or another regulated industry
Knowledge of ISO 13485 and quality management systems in a regulated environment
Experience with supplier quality management or supplier control
Experience working with electronic Quality Management Systems (eQMS)
Experience maintaining or working with a Master Validation Plan in a regulated environment
Experience coordinating or administering training within a Quality Management System
Good documentation and communication skills
Strong command of English, written and spoken
Meriting qualifications
- Experience from the medical device or in vitro diagnostics industry and knowledge of IVDR (EU 2017/746)
- What we're looking for in you
You're proactive, structured, and solution-oriented, with a strong quality mindset and an eye for detail. You enjoy working hands-on and taking ownership of tasks from planning through implementation and follow-up. You work well independently but collaborate easily across the organization, communicate clearly, and build strong professional relationships. You thrive in a dynamic environment where priorities can shift and where continuous improvement is part of everyday work.
At A3P Biomedical, you'll join an ambitious, entrepreneurial team with a global mission: improving men's health and transforming prostate cancer diagnostics. Your work will have direct clinical impact. If you want to be part of a growing company that values collaboration, curiosity, and quality, we'd love to hear from you.
Learn more about us at A3P Biomedical.
Submit your application in English. Selection and interviews are held continuously, so don't wait to apply — the position may be filled before the application period closes.
This position is based in Stockholm or Uppsala, Sweden.
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