Quality Engineer

We are working on an exciting Quality Engineer role for a large medical device client in Clonmel.

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• Develop an in-depth knowledge of the manufacturing engineering process for the scope’s products including all aspects of engineering production and process controls in place on these manufacturing lines.
  
• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), and production control plans in support of product transfer to ensure meets Quality engineering standards
  
• Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.
  
• Lead the translation and establishment of all Process Monitoring and activities, Acceptance Activities and inspections, and non-conforming material and product controls for the Scopes assembly lines in Clonmel.
  
• Post-transfer identifies and controls Quality manufacturing engineer-related process defects (scrap, nonconforming material, customer complaints) by participating/leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
  
• Leads Quality engineering process improvement efforts by identifying methods to capture Quality metric data and by performing appropriate Quality analysis methods to enhance sustaining product design and new product development.
  
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using eCAPA and Engineering Essentials.
  
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality engineering issues.
  
• Be part of a strong team culture around high expectations & high performance.
  
• Provide clear communication to stakeholders at key technical updates.
  
• Support and prepare for site level internal and external audits.
  
• Support the transfer of the production lines
  

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• 2-5 years’ experience in Manufacturing or Quality with a honours degree qualification in Engineering or related technical/Quality discipline.
  
• Excellent written and verbal communication skills
  
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
  
• Strong command of MS Office – Word, Excel, PowerPoint.
  
• Ability to rapidly learn and use new applications
  

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• Previous experience in a Quality, or Manufacturing background.
  
• Experience in the medical device industry.
  
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
  
• Experience in problem solving and process improvement methodologies. xcfaprz
  
• Process Validation, Risk Management, CAPA experience.