Quality Engineer at A3P Biomedical

A3P Biomedical AB (publ); Jönninge; On-site; SEK 550,000 - 750,000; Full time

Job summary

A3P Biomedical AB is seeking a Quality Engineer to join the Quality & Regulatory Affairs team in Sweden. You will own supplier control, administer the eQMS, and maintain the Master Validation Plan, ensuring compliance and continuous improvement in a regulated environment.

The role demands hands-on quality work, ownership mindset, and collaboration with Operations, Regulatory Affairs, and R&D to improve patient outcomes through better diagnostics.

Qualifications

• BSc or MSc in Engineering, Life Sciences, Biomedical Engineering, Biotechnology, or a related discipline.
• Experience in QA or Quality Engineering in medical devices or regulated industries.
• Knowledge of ISO 13485 and quality management systems in regulated environments.
• Experience with supplier quality management or supplier control.
• Experience with electronic Quality Management Systems (eQMS).
• Experience maintaining or working with a Master Validation Plan.
• Experience coordinating or administering training within a QMS.
• Strong documentation and communication skills.
• Fluent English, written and spoken.
• Experience in medical devices or IVDR (EU 2017/746).

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 and followed.
• 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 maintenance and continuous improvement of the QMS in line with requirements.
• Collaborate with Operations, Regulatory Affairs, R&D, and other functions to ensure compliant quality processes.

Skills

Quality Assurance

Quality Engineering

Documentation

Communication

English

Regulated industry

Supplier quality

Training administration

Education

BSc/MSc in Engineering or Life Sciences

Tools

eQMS

Job description

Kommun: Uppsala

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


• 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.

This position is based in Stockholm or Uppsala, Sweden.

A3P Biomedical AB

A3P Biomedical AB (publ)