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Design Assurance Engineer - Developed Start-up

Job description

Design Assurance Engineer – Developed Start-up

Responsibilities:

  • Act as a key person within the DA function, advising on new technology and breakthroughs in the MedTech sector in regulations and standards.
  • Work cross functionally, performing project management as needed, with the other functions providing support in relation to DA, specifically specification development and design development.
  • Provide guidance in relation to development of protocols, reports, procedures, deviations and change requests daily.
  • Work on and develop design verification and validation plans, protocols, risk assessments and reports.
  • Will Co-ordinate the design history file for designated projects and helping with compliance projects and documentation.
  • Support ISO inspections and registrations while also ensuring the quality policy and company systems and procedures are complied with.
  • Lead internal audits and review change controls and complete qualification for NPD and NPI projects.

 

Requirements

  • Engineering degree with 5 years’ experience in a pharmaceutical or medical device environment.
  • Must have 5 years in a Quality or DA function in a medical device company or a high level of understanding of design assurance, six sigma or design for manufacturing.

  

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

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