Biocompatability ‘SME’ Quality Engineer required by market-leading medical devices company in Galway – to play a key role in developing and leading sterilisation validation for existing & new products. Do you want to be part of a growing Irish success story? 

Key Responsibilities:

  • Site ‘Subject Matter Expert’ for all Biocompatability activities
  • Provide technical excellence in the field and selection of testing strategies and materials
  • Develop Sterilisation plans and Lead sterilisation validation for new products and related change control
  • Ensure compliance to all relevant regulations for sterilisation and microbiology 
  • Collaboratively work with external contract sterilization test facility and contract testing services
  • Support Operations and R&D Project Teams with respect to Biocompatability testing strategies and sterilization validation requirements
  • Management of process deviations, NCRs and CAPAs related to Bicompatability & Sterilisation Processes
  • Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to biocompatibility and sterilisation

Requirements: 

  • Bachelor’s Degree in Science / Engineering – Level 8

  • 5+year’s experience in a quality engineering role with experience in sterilisation or microbiology 

  • Experience in the Medical Device sector with good understanding ISO 13485 and FDA QSR standards

  • Supplier/Internal Auditing experience

  • Excellent  communication skills – verbal & written

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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