LSC have a great contract opportunity for a Quality Engineer to join a multinational medical device company based in Cork. The Cork facility is a global centre for product development, manufacturing and supply chain.
If you have a minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
o Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
o Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
o Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges
o Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
o Approve IQ, OQ, PQ, TMV or Software Validation
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Experience working in both an FDA and European regulatory environment is preferred.
o This position will require relevant experience working in manufacturing/operations.
o In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
o Experience with a proven track record of implementing appropriate risk mitigation.
o Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
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 Paul O’ Driscoll at LSC on 021-4777329 if you have anymore questions about this Quality Engineer opportunity!