LSC seeks a Quality Engineer for a Cork based medical device multinational. The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.
The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business
The Quality Engineer will:
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 Conduct benchmarking to develop more effective methods for improving quality
o Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
The Quality Engineer requires:
o A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 2-4 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 preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
o Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
o Demonstrated project management and project leadership abilities are preferred.
Contact Martin today on 0214777329 for a further discussion or respond directly to this advert with your CV.