Quality Management Officer (QMB)

Would you like to drive quality processes for a cutting-edge medical software company?

 

Are you passionate about contributing to the modernisation and improvement of healthcare?

 

We're searching for a QMB for our pioneering MedTech client in Munich! Could this be your next step?

 

Key Responsibilities:

• Serve as the Quality Management Representative, overseeing all aspects of QMS document management, including creation, revision, and approval processes
• Lead the CAPA process to ensure timely identification and resolution of non-conformities
• Coordinate both internal and external audits
• Provide training and ongoing support to staff on quality-related topics
• Conduct management reviews to evaluate and report on the compliance and effectiveness of the QMS
• Draft and evaluate technical documents in line with MDR, regulations for non-EU countries, US FDA 21 CFR
• Oversee risk management following ISO 14971

 

Requirements:

• A degree in Biomedical Engineering or a related field
• Experience in Quality Management for Medical Devices, including development and/or maintenance of a QMS, as well as participating in internal and external audits
• Strong knowledge of ISO 13485, MDR, ISO 14971, and standards such as ISO 62304, ISO 62366,
• Skilled in coordinating processes and providing guidance to colleagues in quality
• Fluency in German and English

 

If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.