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?
- 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.
- 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
+353 (0) 83 0220666