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Quality Assurance and Compliance Professional

1 week ago

Stockholm, Stockholm, Sweden QBtech AB Full time

Job Description

We are seeking a highly skilled System Quality Regulatory Manager to join our global team. As a key member of our organization, you will play a critical role in ensuring the quality and compliance of our medical devices.

The ideal candidate will have experience working with Medical Device Software Development, adequate scientific education, and strong communication skills. You will be responsible for maintaining the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR 820, and other country-specific medical device legislations.

Key Responsibilities

  • Maintain the QMS in compliance with relevant legislations.
  • Coordinate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
  • Perform internal and supplier audits.
  • Ensure document and record control.
  • Responsible for CAPA, Change Control, Complaints, and Non-Conformances.
  • Perform training in quality and regulatory matters.