Quality Assurance Manager

2 days ago


Stockholm, Stockholm, Sweden QBtech AB Full time
Transforming Healthcare

Qbtech AB is a leading global company in professional ADHD tests. Our vision is to empower clinical and financial decision-makers to improve outcomes and support patients to better understand their symptoms and treatment. We are looking for a System Quality Regulatory Manager to join our global team.

About the Role

The SQR Manager will ensure compliance with relevant legislation and correct implementation of the Quality Management System at Qbtech's headquarters and subsidiaries in Europe and the USA. This role requires knowledge of ISO 13485, 21 CFR 820, and other country-specific medical device legislations. The successful candidate will be responsible for internal and supplier audits, document control, CAPA, Change Control, Complaints, and Non-Conformances. They will also perform training in quality and regulatory matters.

Required Skills and Qualifications

The ideal candidate has experience in Medical Device Software Development and Quality Management. They should have a BSc or higher degree, verbal and written English proficiency, and the ability to pass a background check. The successful candidate must have knowledge of Regulation (EU) 2017/745, US 21 CFR Part 820, ISO 13485:2016, and ISO 27001.

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