![QBtech AB](https://media.trabajo.org/img/noimg.jpg)
Quality Assurance Manager Medical Devices
6 hours ago
Compliance Expert Wanted
Qbtech, the global market leader in professional ADHD tests, seeks a highly skilled Regulatory Affairs and Quality Manager to join our team.
About the Position
The selected candidate will be responsible for maintaining our Quality Management System (QMS) in accordance with relevant legislation(s). They will also provide critical support to Qbtech in meeting regulatory requirements for medical devices.
Duties and Responsibilities
- Assist in preparing 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.
- Collaborate closely with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
- Conduct internal and supplier audits.
- Oversee document and record control.
- Responsible for CAPA, Change Control, Complaints, and Non-Conformances.
Requirements
- Adequate scientific education, BSc or higher.
- Previous experience working with Medical Device Software Development.
- Excellent verbal and written English skills.
- Able to undergo a background check.
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