Job Description

RA/QA Manager (id 1872)

Belgium Medical Devices
Posted by Luc Decat on 14/12/2020

If you have some relevant experience in QA and/or RA for Medical Devices, then this might be a great opportunity for you:  We are looking for a RA/QA Manager Medical Devices Software.

Mission:

  • Manage all activities as required by the (integrated) Quality Management System which is built according to the requirements of both ISO 13485:2016 and ISO 27001:2013 and ensure they are carried out in a manner that is compliant with the applicable regulatory requirements.
  • Define the strategic roadmap for NDTE, such as compliance to additional standards or define constraints and boundaries for its product suite.
  • Perform work for required activities as defined in the QMS or the roadmap.

Job Responsibilities:

  • Manage quality in the product development lifecycle
    • Setup / improve review processes, design verification and validation processes and change control processes
  • Conduct (patient and security) risk management activities
    • Risk analysis
    • Setup and follow-up on risk reduction activities
    • Document and keep procedures up to date
  • Manage quality events
    • Handle non-conformances
    • Setup / improve customer complaint processes
    • CAPA activities
    • Document and keep procedures up to date
  • Documentation management
    • Ensure policies, procedures and instructions are compliant and kept up to date
    • Ensure the medical device file(s) are compliant and kept up to date
  • Training management

Profile & Skills:

  • Master’s Degree in Life Sciences or Engineering or similar by experience
  • Knowledge of MDR/IVDR
  • Relevant experience in Quality Assurance and/or Regulatory Affairs for medical devices
  • Knowledge on medical device quality management for software as a medical device
  • Fluent in English
  • Comfortable working in a full digital environment
  • Experience with software development activities is a plus
  • Excellent communication skills
  • Reside in Belgium

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