Quality Engineer Biocompatibility and Sterilisation – Galway

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? 

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:

  • BSc. in Science / Engineering.
  • 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.
  • Must be authorised to work in Ireland.

Please contact Mary-Ann Keena to learn more

maryann@emtechrecruitment.ie

+353 (0) 83 0220666

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