Company: Sigmar
Location: Galway, Galway

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Quality Manager – Post Market Surveillance 

Work in a world leading medical device company renowned for their product excellence and development. They are going through a large expansion in line with developing a centre for excellence in product and patient safety. There are huge opportunities to be involved in the next generation for medical devices and international projects. Address key issues regarding complaint handling and regulatory reporting, developing a clear strategy on how to continuously improve the medical devices developed onsite and across the globe.

Responsibilities:

  • Contribute and develop the framework and strategy for complaint handling activities, utilizing trend analysis to further patient safety and product excellence
  • Have oversight over Global Medical Device reporting, dealing with external agencies and ensuring total compliance to MDR, FDA, ISO and other regulatory standards. Similarly, reviewing key performance indicators to address any ongoing issues within device performance
  • Oversight over risk management including risk analysis and health hazard analysis
  • Manage and ensure development of QMS and Post Market Surveillance Quality Documentation
  • Support global PMS issues

 Requirements:

  • Must have a level honours degree with 7 years or more experience within the Medical device sector with both Management and Complaint handling or medical device investigation exposure
  • People management experience is essential and should have a thorough understanding of the CAPA process

 

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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