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Validation Engineer

Job description

Looking for an experienced Validation Engineer to join a leading medical devices company based 15 minutes from Cork City!

Job Responsibilites 

  • 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

Job Requirements

  • 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 / marcel@sigmar.ie

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