Quality Engineer, Medical Devices & eQMS Leader

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

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.