
Medical Device Quality Lead
5 days ago
Maintaining Excellence in Quality Management
We are looking for a seasoned Regulatory Compliance Manager to join our team at QBtech AB.
The successful candidate will be responsible for maintaining and updating our Quality Management System (QMS) in accordance with relevant legislation and ensuring its correct implementation at our headquarters and subsidiaries in Europe and the USA.
Key Accountabilities- Ensuring compliance with relevant legislation and regulatory requirements.
- Providing expert knowledge in Qbtech Management Systems, including ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and other country-specific medical device legislations.
- Collaborating with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
- Performing internal and supplier audits.
- Ensuring document and record control.
- Managing CAPA, Change Control, Complaints, and Non-Conformances.
- Providing training in quality and regulatory matters.
- Acting as deputy to the QARA Manager in headquarters and/or QARA Manager at QBtech US site.
- Relevant experience in Medical Device Software Development.
- Scientific education, BSc or higher.
- Experience in Quality Management in accordance with ISO 13485 and US 21 CFR Part 820.
- Excellent verbal and written English proficiency.
- Able to pass a background check.
At QBtech AB, you will have the opportunity to work on meaningful projects that help people understand ADHD while transforming healthcare. You will collaborate with international experts, lead the development of best-in-class products and services, and enjoy opportunities for learning and growth.
This role has a hybrid remote setting, with at least 3 days in the Stockholm office per week. Some domestic and international travel is required.
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