Our client is a medical device manufacturer with a strong focus on the US market/ FDA 510k submissions, where 50% of their customers are based.
To strengthen the team, they are searching for a QMB to lead with FDA compliance in quality documentation, manufacturing and lead a small team.
Responsibilities of the QMB:
- Development and documentation of a quality management system that meets the requirements of DIN EN ISO 13485 and US Quality System Regulation (21 CFR 820)
- Audit planning and ensuring regular execution of quality audits.
- Regular reporting on the performance of the system as a basis for improvement.
- Ensuring the implementation of enterprise policy and further development of the management system, including the adaptation of documentation.
- Adaptation of the Quality Management System (QMS) to changing objectives of the company, organizational structures and the current status of legal requirements.
- Preparation, modification and distribution of the documents relating to the QMS, incl. QM manual in cooperation with the departments.
- Initiation of appropriate quality training and training measures for the QMS.
- Assessment of suppliers.
- Customer and supplier support in quality issues.
- Participation of sector-specific quality promotion programmes.
- Professional representation of the management in dealing with authorities, external certification bodies, professional associations and in quality matters of customers.
- Degree in Engineering of Medical Technology field.
- Several years of professional experience in quality management for medical devices.
- Must be fluent English and German, including writing to complete quality documentation.
- Due to the strong US presence, the QMB must be able to confidently communicate with American customers and with FDA, including audits.
- Extensive experience with US Quality System Regulation (21 CFR 820)
- Leadership experience is a bonus.
For more information about this opportunity or others in quality management, please contact Rebecca Stevens at Rebecca.firstname.lastname@example.org or +44 208 638 5376.