System Quality Management Specialist

12 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time
Compliance and Regulation in Medical Devices

The System Quality Regulatory Manager will be responsible for ensuring compliance with relevant legislations and regulations, including ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and other country-specific medical device legislations.

This role requires strong knowledge of Quality Management Systems and experience with auditing and inspection processes. The ideal candidate will be able to pass a background check and have excellent verbal and written English proficiency.

Responsibilities of this role include:

  • Ensuring document and record control.
  • Responsible for CAPA, Change Control, Complaints, and Non-Conformances.
  • Performing internal and supplier audits.


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