LSC have a great contract opportunity for an EUMDR Quality Engineer to join a Multinational Medical Device Company in Cork.
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Work in a cross functional team with Project Management, R&D, Design Quality, Engineering, Operations and Supplier Management to ensure successful EUMDR implementation.
o Provide support to Design Quality and R&D to understand manufacturing and process controls for development of Hazard Analysis, Design FMEA’s and DV Protocols and Reports.
o Lead conversion of legacy Process FMEAs to new Global PRA format to comply with EU MDR requirements.
o Support conversion of legacy MVPs to the new Global MVP template to meet EUMDR requirements.
o Support any Process validation remediation activities required for EUMDR submission.
o Drive risk reduction and eliminate risks and introduce error proofing through the Risk Management 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 remediation activities required for EUMDR.
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 EUMDR Quality Engineer opportunity!