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Complaints Technical Investigator Engineer

Job description

Complaints Technical Investigator Engineer

Reporting to the Senior QA Engineer, this position has been created due to the growth of the company. The successful candidate will ensure the execution of technical investigations of all complaints (including feedback) in a thorough and timely manner, in line with the company procedures.

Responsibilities:

  • To perform Technical Analysis of returned products
  • Identify the actual nature of the device non-conformance
  • Perform a Technical Analysis of the procedure angiographic data (Angiograms, X-Ray, Ultrasound etc.) as part of the investigation into the cause of a complaint.
  • Analyse the anatomical circumstances in which the Complaint arose and consider these in the context of the complaint occurrence and investigation.
  • Liaise with the Chief Medical officer in the execution of the above activities, so as to benefit from the CMO expert opinion
  • Liaise with Physicians, Hospital Staff, Distributors, Suppliers as necessary to ensure a well-informed, thorough, and timely investigation.
  • Consider the need for Corrective and Preventive actions (CAPA) that arise from the investigation and ensure that these are initiated in the CAPA system
  • Perform a review of the Risk Management File in order to determine if an update to the Risk Management file is required and ensure this is initiated.

Education:

  • Upwards of 4 years’ experience in a medical device manufacturing environment. This must include significant experience in the Design and Manufacture of Vascular Stents and Stent Delivery Systems
  • Educated at minimum to a Diploma Level in an Engineering, Science or Quality Assurance discipline is required
  • A formal qualification in a discipline that ensures a solid understanding of the vascular anatomy is highly desirable
  • Training in the analysis/interpretation of clinical angiographic data is essential

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@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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