LSC have a great contract opportunity for an NPI Quality Engineer to join a Multinational Medical Device Company in Cork.
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Ensure all process changes/process improvements are risk assessed by promoting the GO SEE Principle and FOCUS ON PROCESS Principle.
o Provide feedback to the R&D teams to ensure the new product is designed for manufacturing.
o Drive risk reduction and eliminate risks and introduce error proofing through the Risk Management process.
o Develop and agree with the master validation strategy for the new product manufacturing process.
o Review and approval of all process characterisation, process validation & test method validation documentation.
o Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
o Complete Attribute TMV’s on new product projects.
o Ensure compliance at all stages of Product Lifecycle Development Process. Reviewer of change notices for product, process and system changes, validation builds and eCAPA phases.
o Promote a right first time behaviour within the New Product Project Teams.
o Provide regular updates to site management on progress of new product introduction activities.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Katie Browne at LSC on 021-4777329 if you have anymore questions about this NPI Quality Engineer opportunity!