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Global Design Assurance Manager - Diagnostics

Job description

Global Design Assurance Manager - Diagnostics

Act as leading manager for global design assurance for medical diagnostics and ensuring the development of devices across multiple sites. This vital position is focused on looking at complaints, product issues, regulatory requirements and updates and above all patient safety and wellbeing.

Responsibilities:

  • Direct global design assurance activities for Europe and Asia
  • Develop and design strategy surrounding change controls and regulatory compliance for device design
  • Ensure Product, Process, Testing Methods and Labelling are all compliant
  • Work closely with R&D and Quality global teams
  • Monitor global post-market surveillance and complaint data to ensure continuous improvement for all new and existing devices
  • Co-ordinate design and design development activities globally
  • Monitor and oversee global design reviews
  • Be a key stakeholder in tech transfers across global sites
  • Participate and manage regulatory investigations, audits and reviews

Requirements:

  • Level 8 degree in engineering or science with 5 years or more in quality or design assurance management
  • Should have proven track record with tech transfers, design assurance projects and developing continuous improvement programs

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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