About this role
Quality Assurance Specialist and Supplier Auditor
About this opportunity
We save lives. Are you passionate about Quality Management and Medical Devices? Do you enjoy supporting and challenging colleagues to find better and more efficient ways of working while improving product quality and maintaining compliance with regulations? Then we have an exciting opportunity for you.
The Quality & Compliance team consists of eleven dedicated professionals who act as ambassadors for quality culture and compliance with medical device standards and regulations, as well as ISO 14001, cybersecurity requirements, and other applicable standards. The team works closely with other teams and colleagues at our site in Solna and in Munich, Germany.
In this role, your primary responsibility will be to support and strengthen quality and compliance activities related to supplier management, audits, quality systems, and continuous improvement initiatives, helping us deliver high-quality products that save lives and maintain customer trust.
What you will do
As a Quality Assurance Specialist and Supplier Auditor, you will play a key role in maintaining and improving our Quality Management System while supporting both internal and external stakeholders.
Your responsibilities will include:
- Being part of the global Supplier Auditor team, working closely with Procurement, Supplier Quality Engineers, and suppliers to ensure product quality and well-defined requirements.
- Acting as a quality advisor to stakeholders across the organization, particularly regarding supplier qualifications and quality agreements.
- Supporting the organization in quality-related matters and driving improvements to procedures within the management system.
- Performing internal audits, identifying opportunities for improvement, and ensuring nonconformities are effectively tracked and closed.
- Participating in preparations for external audits, management reviews, and supporting the CAPA (Corrective and Preventive Actions) process.
This position is based in Solna, Stockholm. The role includes close collaboration with global stakeholders and suppliers and requires travel to conduct approximately eight supplier audits annually, in addition to other supplier and audit-related activities. A hybrid working arrangement may be possible depending on business needs.
You will bring
To be successful in this position, we believe that you have the following qualifications:
- Academic degree (B.Sc. or M.Sc.) in Engineering, Science, or a related field.
- At least five years of experience in a similar quality-relat