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Senior Quality Engineer - Complaints

Job description

Senior Quality Engineer – Complaints

One of the world’s largest medical device companies and Irelands second largest employer with a growing site and plenty of NPD and NPI projects. This site is a center for product development and excellence with patient care at the centre of everything done on site.

Responsibilities

  • This senior position will oversee complaint investigation while updating and maintaining the onsite QMS to ensure Post Market Surveillance requirements are met and ensure product quality and patient safety are effectively focused on.
  • Lead investigations and ensure records are properly stored on the global complaints system.
  • Provide direction and guidance regarding product complaints and also provide insights into product performance globally.
  • Ensure compliance for the department to both company policies and procedures and also FDA, BSI and EEO regulations too.
  • Work closely with suppliers and customers during investigations.
  • Work cross functionally with Quality Operations, DA and R&D to ensure high product performance in the field.
  • Perform trend analysis and implement continuous improvement throughout the complaints departments functions.

 

Requirements

  • Level 8 degree in stem subject with 5 years or more in medical device complaints investigations.
  • Should have prior team management skills and working knowledge of regulatory requirements for FDA, BSI or others.

 

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

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