Looking for an experienced Validation Engineer to join a leading medical devices company based 15 minutes from Cork City!
- Supporting Manufacturing process validation.
- Validating the manufacturing process
- Performing statistical analysis to prove the manufacturing process capability
- Supporting in overall delivery of the project.
- Verifying and validating several machines and various process involved in it.
- Responsible for IQ/OQ/PQ methodologies and report generation.
- Preparing document in business process by identifying the business requirements.
- Understanding functional specifications and system design specifications for client
- Implementing and following the operational standards, policies and procedures.
- Mitigating risks reported during the project
- Documentation of process change in engineering change management system
- Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk assessment
- Techniques to evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
- Knowledge of any 3D CAD software.
- Strong Technical Knowledge in Manufacturing Engineering
- Knowledge in test method development validation, development and transfer.
- Knowledge in stages of qualification like design, installation, operational and performance.
- Knowledge in preparing manufacturing process control flow chart.
- Knowledge in Risk management and Change management process.
- Knowledge in creation of Pareto chart, why-why analysis, cause & effect diagram for analysis
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / firstname.lastname@example.org
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