System Quality Assurance Professional

2 days ago


Stockholm, Stockholm, Sweden QBtech AB Full time
Ensuring Quality and Compliance
We are seeking a highly motivated and experienced System Quality Regulatory Manager to join our team. As a key member of our organization, you will be responsible for ensuring our Quality Management System remains updated and compliant with relevant legislation, including ISO 13485, 21 CFR 820, and EU-MDR 2017/745.

In this role, you will coordinate and host inspections and audits from notified bodies and authorities, provide expert advice on Qbtech Management Systems, and collaborate with the Product Development Team to ensure medical device legislations are met. You will also perform internal and supplier audits, ensure document and record control, and oversee CAPA, Change Control, Complaints, and Non-Conformances.

What We Offer

You will have the opportunity to work with a dynamic team, develop your skills and expertise, and contribute to the development of innovative healthcare solutions. Our company offers a competitive compensation package, opportunities for growth and advancement, and a collaborative work environment.



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