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.

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

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For more information, please reach out directly to Emma Mullen on +353 87 636 9263 or