A global distributor and manufacturer of medical supplies and pharmaceutical products. Undergoing global corporate projects currently, seeking an experienced engineer to join their projects team. On a team of 10 engineers, you will report directly to the engineering project manager.
Coordinate implementation of new materials to support the MDR requirements/remediation
Support process and product validation executions ensuring validations meet pre-determined acceptance criteria.
Critical Process validation protocols and reports - identify the critical validated processes. Provide validation reports that support the validation of the device manufacturing process, testing, and environmental controls.
Root cause and problem solve production issues for Manufacturing Machines.
Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
Continuously communicate status of projects and programs with regard to timing, objectives and roadblocks
Work with cross functional teams to ensure objectives and timelines are being met
Device Master Records - A thorough process assessment to ensure the process reflects the manufacturing process in line with the DMR
Manufacturing flow charts -A detailed overview of the manufacturing processes Identifying any critical processes.
Participate in our Risk Management program, identifying the critical to quality characteristics (CTQs) for each product code, quarterly updates to our risk management file
A degree in Engineering / Technical discipline with minimum 3 years relevant quality engineering experience in a medical device/pharmaceutical environment.
Process Validation experience essential
Experience on projects from conception to completion, cost savings and process improvements will be beneficial
Knowledge of Six Sigma & Lean Manufacturing Techniques
For more information, please reach out directly to Emma Mullen on +353 87 636 9263 or