QMB

  • Location

    Germany

  • Sector:

    Quality

  • Contact:

    Rebecca Stevens

  • Contact email:

    rebecca.stevens@adaptivelifescience.com

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.

Experience required:

  • 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.stevens@adaptivelifescience.com or +44 208 638 5376.