System Quality Assurance Expert

10 hours ago


Stockholm, Stockholm, Sweden Qbtech Full time

The ideal candidate for this System Quality Regulatory Manager role will have a strong background in Medical Device Software Development and Quality Management. You'll be responsible for ensuring our QMS remains compliant with regulatory requirements and industry standards, including ISO 13485, 21 CFR 820, and EU-MDR 2017/745.

You'll work closely with cross-functional teams to design, develop, and maintain medical devices, while performing internal and supplier audits, document and record control, and CAPA, Change Control, Complaint, and Non-Conformances.

To excel in this position, you'll need knowledge of Regulation (EU) 2017/745, US 21 CFR Part 820, ISO 27001, and Medical Device Software Development. Strong communication and interpersonal skills are essential for success in this role.



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