Senior Quality Assurance Specialist

3 days ago


Uppsala, Uppsala, Sweden Sysmex Astrego AB Full time

About Sysmex-Astrego AB

We are a leading company in the development and manufacture of innovative medical devices.

Our AST system offers rapid, sensitive, and precise Antibiotic Susceptibility Testing (AST) in a completely automated analyzer for use in near patient and central laboratory settings.

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
  • Create, review, approve, and publish quality-regulated documentation
  • Participate in CAPA, Non-conformance, and complaint investigations
  • Lead risk management for products, processes, and equipment
  • 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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