LSC are looking for a Project Quality Engineer for a 12 month contract position with our Cork based Orthopaedic Manufacturing Client.
The Project Quality Engineer will:
” Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Technology) into production with the highest level of quality, compliance, and adherence to timelines
” Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
” Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
” Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
” Liaise with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
” Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
The Project Quality Engineer requires:
” A degree level or similar qualification in mechanical or industrial engineering.
” Minimum 1 years’ experience in a quality role within a regulated industry.
” Proven ability to successfully introduce new product development in the Medical Device Industry.
” Proven knowledge and ability regarding product verification and process validations.
” Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
Call Ruth at LSC on 021 4777329 for more information on this new Project Quality Engineer role, or apply directly via this advert.