LSC Seeks a Quality Engineer for a multinational medical device company based in Cork.
The Quality Engineer, plays a key role in the planning and execution of validation activities related to product transfers, new technologies, process changes and inspection methods. Lead test method validations and provides support for the validation activities associated with equipment and processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.
The Quality Engineer will be responsible for:
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) are in compliance 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 Lead and maintain Material Review Board
o Approve IQ, OQ, PQ, TMV or Software Validation
o Partners with the companies Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
o Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
o Ensures effective quality strategies are created for the validation of test methods, process and design.
The Quality Engineer will require:
o A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
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 required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
If you would like to know more about Quality Engineer role, please contact Martin @ LSC on 021-4777329 or apply directly through this advert.