Quality Management Professional
7 days ago
Sysmex Astrego AB is a leading company in the development and manufacture of innovative medical devices.
We offer a dynamic and international workplace with opportunities for professional growth and development.
About the Role
We are seeking an experienced Senior Quality Assurance Specialist to join our Quality Assurance & Regulatory Affairs team in Uppsala. In this role, you will be responsible for implementing and maintaining our quality management system, ensuring compliance with industry standards and regulations.
Key Responsibilities:
- Implement and maintain eQMS (Greenlight Guru)
- Develop and maintain company processes and documentation according to ISO 13485:2016 and IVDR 2017/746
- Qualifications & Experience:
- Master's degree in a relevant field (e.g., Biology, Engineering, Quality Assurance)
- Minimum of five years of experience in a similar role within the medical device/IVD sector
- Strong knowledge of ISO 13485:2016 quality management systems
- Experience with Greenlight Guru is a plus
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