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Design Assurance Engineer - Start-up

Job description

Design Assurance Engineer – Start-up

Responsibilities

  • Work within the QMS and Quality Policy in line with the MDD 93/42/EEC, Medical Device Directive 2007/47/EC, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
  • Support the development and evolution of Design Control, Risk Management and Product Development.
  • Use your understanding of regulatory requirements for Medical Device developments, participating in specification development and advising on overall design.
  • Assist R&D team for design reviews.
  • Support non-clinical studies.
  • Establish and maintain the design history file and associated documents.
  • Work cross functionally across the quality function.
  • Participate in company Audits and CAPA programs

 

Requirements

  • Degree in Engineering or Science with two years or more experience in medical device or pharmaceutical environments.
  • Must have ISO13485, 21 CFR 820, MDD/MDR, Risk Management and QMS experience.
  • Ideally would have Nitinol experience.

 

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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