The Company

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.

The Role

• 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

The Person

• 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