System Quality and Compliance Expert

8 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time

Transforming Healthcare Together

Qbtech AB is a global leader in professional ADHD tests, aiming to transform healthcare through innovative solutions. We seek a highly skilled Quality Assurance Manager Medical Devices to join our team.

About the Position

The successful candidate will play a crucial role in ensuring our Quality Management System (QMS) remains up-to-date and compliant with relevant legislation(s). They will also support Qbtech in fulfilling regulatory requirements when medical devices are designed, developed, manufactured, and distributed to target markets.

Key Responsibilities

  • Act as the primary point of contact for inspections and audits by notified bodies and authorities.
  • Offer expert guidance on Qbtech Management Systems, including ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and country-specific medical device legislations.
  • Closely collaborate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
  • Conduct internal and supplier audits.
  • Ensure document and record control.
  • Responsible for CAPA, Change Control, Complaints, and Non-Conformances.

Requirements

  • Adequate scientific education, BSc or higher.
  • Experience in Medical Device Software Development.
  • Excellent English language skills.
  • Able to pass a background check.


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