![QBtech AB](https://media.trabajo.org/img/noimg.jpg)
System Quality and Compliance Expert
8 hours ago
Transforming Healthcare Together
Qbtech AB is a global leader in professional ADHD tests, aiming to transform healthcare through innovative solutions. We seek a highly skilled Quality Assurance Manager Medical Devices to join our team.
About the Position
The successful candidate will play a crucial role in ensuring our Quality Management System (QMS) remains up-to-date and compliant with relevant legislation(s). They will also support Qbtech in fulfilling regulatory requirements when medical devices are designed, developed, manufactured, and distributed to target markets.
Key Responsibilities
- Act as the primary point of contact for inspections and audits by notified bodies and authorities.
- Offer expert guidance on Qbtech Management Systems, including ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and country-specific medical device legislations.
- Closely collaborate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
- Conduct internal and supplier audits.
- Ensure document and record control.
- Responsible for CAPA, Change Control, Complaints, and Non-Conformances.
Requirements
- Adequate scientific education, BSc or higher.
- Experience in Medical Device Software Development.
- Excellent English language skills.
- Able to pass a background check.
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