Validation Engineer (Medical Device)
Posted on Dec 20, 2020 by Dabster Systems
Role: Validation Engineer
Job Type: Permanent/Contract
Location: Cork, Ireland
- End to end support of Manufacturing process validation.
- validate the manufacturing process
- Perform statistical analysis to prove the manufacturing process capability
- Support in the overall delivery of the project.
- Responsible for verifying and validating several machines and the various processes involved in them.
- Responsible for IQ/OQ/PQ methodologies and report generation.
- Preparing documents in the business process by identifying the business requirements.
- Understanding functional specifications and system design specifications for client engagements.
- Analyze issues recurrence to identify patterns and gaps identification, drive root cause
- analysis, and translate findings into solutions to improve workflows, processes, and tools
- Interaction with manufacturing and design team to identify improvement areas in
- manufacturing process
- Interaction with the supply chain management team related to manufacturing activities
- Implementation and follow operational standards, policies, and procedures.
- Optimization of manufacturing processes and methodologies
- Mitigate risks reported during the project
- Documentation of process change in engineering change management system
Added advantage - Knowledge in the below topics.
- 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 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, operation and performance.
- Knowledge in preparing manufacturing process control flow chart.
- Knowledge in Risk management and Change management process.
- Knowledge in the creation of Pareto chart, why-why analysis, cause & effect diagram for analysis.