Quality Engineer x 2 for 12 month contract with leading Medical Devices company in Cork city.
These roles will suit candidates with at least 2 yrs experience gained within a regulated FDA environment and have a skill set which includes the following skills;
This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
Please get in touch for a more detailed JOb Description on 022 46969 or email firstname.lastname@example.org