A global distributor and manufactruer of medical supplies and pharmaceutical products. Undergoing global coroporate 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.
- 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