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QMS manager MDR FREELANCE

Location: Best - Noord-Brabant - Netherlands

Job: Medical Device - Contract

For a leading Medical device client in the North Brabant area I am looking for a QMS manager with with  EU MDR experience.
You will be acting as Program Manager for PQMS/PEPF and EU MDR deployments in the Market organization, providing status updates to relevant stakeholders in a timely manner.

RESPONSIBILITIES:

  • You will be managing the QMS transition of the QMS/PEPF and EU MDR and manage the deployments in the Market organizations. 
  • You will locally manage plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the Market OneQMS. 
  • You will ensure the creation and management of any local QMS documents are in line with the evolution of the PEPF, the PQMS and EU MDR requirements. 
  • You will work with (Local) Business Process Owners, Business Process Experts, Market Deployment team, E2E Q&R, local Q&R and EU MDR Work Streams in order to manage PEPF, PQMS and EU MDR deployments 

PROFILE

  • You have a Bachelors or Masters degree in a Scientific field
  • You have a minimum of 5 years working experience
  • Good organizational and Program/Project management skills 
  • Great knowledge of ISO 9001 and ISO 13485 (preferable ISO 9001:2015 and ISO 13485:2016) 
  • Knowledge of MDD and EU MDR/IVDR 
  • You have strong analytic skills 
  • Demonstrated ability to understand and develop processes. 
  • Professional English written and verbal communication skills 
  • Ability to work under a minimum of supervision 

PROJECT DURATION

31/12/2019

PROJECT START DATE

July

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

For further information, please contact Loretta Kumi at +31 (0)20 20 44 502 or by email at L.kumi@panda-int.com.

PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.

Reference: vr6054

INTERESTED?

If you see yourself in this role, please apply by uploading your CV via the apply for this position button. We will review your application and get in touch with you to discuss things further.

For more information, please fill in the form below or call us on +31 (0)20 20 44 502.

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