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Design Assurance Engineer II

Job description

Design Assurance Engineer II

Responsibilities

  • You will demonstrate and instil in your work a commitment to improving patient safety, customer satisfaction and product quality.
  • Ensure compliance to quality, business, H&S systems, legal regulations and the internal QMS.
  • Work together with R&D, Regulatory Affairs, Clinical, Medical Safety, Post Market Surveillance and Complaints Management to provide technical and quality systems guidance.
  • Provide support in design quality for the resolution of PIRs, complaints investigations, CAPAs and regulatory requirement changes.
  • Deliver the highest quality into all aspects of your work and resolve complex problems in product design.
  • Be an active leader and coach others, giving technical leadership to junior team members.
  • Actively implement change to practices and implement appropriate risk management and statistical analysis.

 

Requirements

  • Level 8 degree in an engineering or science discipline with 3 years or more working in a medical device or highly regulated environment.
  • Must be experienced in post market complaints support, risk management, design and process change and compliance to regulatory requirements.

 

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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